Category: 3. Business

Nine-month findings show mean improvement in Composite Unified Huntington’s Disease Rating Scale from baseline of +0.64 points, compared to natural history expected worsening of cUHDRS in symptomatic patients of -0.73 points over nine months, based on propensity score weighting.

Skyhawk also announces SKY-0515’s Phase 2/3 FALCON-HD trial has expanded worldwide. Skyhawk has now dosed more than 90 patients.

BOSTON, Jan. 27, 2026 /PRNewswire/ — Skyhawk Therapeutics, Inc., a clinical-stage biotechnology company developing novel small molecule therapies to modulate critical RNA targets, today announces positive results from the nine month interim analysis of the Company’s investigational treatment for Huntington’s disease (HD) with SKY-0515.

Treatment with SKY-0515 results in dose-dependent reductions of mHTT protein in blood of 62% at the 9mg dose, and dose-dependent PMS1 mRNA reduction of 26%. PMS1 is a key driver of somatic CAG repeat expansion and HD pathology. SKY-0515 has also demonstrated excellent central nervous system exposure and been generally safe and well tolerated.

At three, six and nine months, patients receiving SKY-0515 in the Part C patient cohort of the Phase 1 clinical trial of SKY-0515, demonstrate mean Composite Unified Huntington’s Disease Rating Scale (cUHDRS) improvement from baseline. At nine months, in a pooled analysis, this improvement is +0.64 points compared to expected worsening at nine months of cUHDRS in symptomatic patients of -0.73 points, based on propensity score weighting using Enroll-HD and TRACK-HD.

“I am very encouraged by these safety and early efficacy data from SKY-0515’s Phase 1 Part C trial in patients, showing divergence in cUHDRS away from expected natural history deterioration at the three, six, and nine month prespecified analyses,” said Ed Wild, Professor of Neurology at University College London. “SKY-0515 continues to reduce mHTT protein to the greatest extent demonstrated by any therapeutic tested to date in patients, with clinical and biomarker data showing the drug is well tolerated at all doses tested. SKY-0515’s ability to reduce both mHTT and PMS1 offers a potent combination for treating Huntington’s disease via two of its core pathogenic mechanisms. These open-label trial results, due to be validated in the ongoing placebo-controlled FALCON-HD trial, give an expectation of meaningful impact for people living with HD across the world – for whom an orally administered huntingtin-lowering treatment such as SKY-0515 will be truly transformative.”

“Our goal for our Phase 1 study was to establish safety and biomarker activity,” said Sergey Paushkin, Head of R&D at Skyhawk Therapeutics, “and the continued strength of SKY-0515’s biomarker response in our nine month interim data analysis – and the improvement in the potential endpoint, cUHDRS, compared to a worsening of the cUHDRS score in the natural history data for patients – underscores SKY-0515’s potential as a best in class disease-modifying therapy for HD. These interim data represent an important milestone for SKY-0515 and highlight the power of Skyhawk’s platform to deliver first-in-class small molecules for devastating diseases with no approved disease-modifying therapies.”

Huntington’s disease is a rare, hereditary, and ultimately fatal neurodegenerative disorder that affects over 40,000 symptomatic patients in the United States, with hundreds of thousands estimated to be affected worldwide. There are currently no approved treatments which slow or halt disease progression. SKY-0515 is an orally-administered, investigational small molecule RNA modulator developed through the company’s novel RNA-modulating platform, SKYSTAR^®. SKY-0515 therapeutically reduces both HTT protein and PMS1 protein. PMS1 is an additional key driver of somatic CAG repeat expansion and HD pathology and should complement the benefits of reducing mutant HTT.

Skyhawk also announces today that its SKY-0515 Phase 2/3 FALCON-HD trial, open at twelve sites in Australia and New Zealand, has expanded worldwide. Skyhawk has now dosed more than 90 patients with SKY-0515. 

SKY-0515 is the first Skyhawk drug in clinical trials.

Skyhawk expects to put additional small molecule drugs to treat rare neurological diseases with no approved disease modifying therapies in the clinic by the end of 2027.

About SKY-0515’s Phase 1 Clinical Study 
SKY-0515’s Phase 1 clinical trial is a first-in-human trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SKY-0515 in healthy volunteers and individuals with early-stage Huntington’s disease (HD). The trial is separated into three parts. Parts A and B evaluated SKY-0515 in Healthy Volunteers. Part C is a double-blind placebo-controlled parallel design study of two dose levels of SKY-0515 and placebo in individuals with early-stage HD (HD-ISS Stage 1, 2, or mild Stage 3) for 84 days followed by a 12 month extension of active treatment where all participants will receive either a low or high dose of SKY-0515 in a blinded fashion. The objectives of the study include evaluating mutant HTT protein and PMS1 mRNA. The first patients were dosed in SKY-0515’s Part C in January 2025. Enrollment in Phase 1C of the SKY-0515 trial is now complete.

About SKY-0515’s Phase 2/3 FALCON-HD Clinical Study 
FALCON-HD (NCT06873334) is a Phase 2/3 randomized, double-blind, placebo-controlled, dose ranging study to evaluate the pharmacodynamics, safety, and efficacy of SKY-0515 in 120 participants with Stage 2 and early Stage 3 HD across 12 sites in Australia and New Zealand, and 400 participants with Stage 2 and early Stage 3 HD in 40+ worldwide sites. Eligible patients will receive a once-daily oral dose of SKY-0515 at one of three dose levels or placebo, for a treatment period of at least 12 months. The trial aims to assess the potential of SKY-0515 to modulate RNA splicing and reduce mHTT and PMS1 proteins, which are implicated in the pathology of Huntington’s disease. Additional information about FALCON-HD, including participating sites and eligibility criteria, can be found at ClinicalTrials.gov and www.FALCON-HD.com.

About Skyhawk Therapeutics
Skyhawk Therapeutics is a clinical-stage biotechnology company which uses its proprietary platform, SKYSTAR^®, to discover and develop small molecule RNA modulating therapies for the world’s most intractable diseases. For more information visit www.skyhawktx.com.

Skyhawk Contact
Maura McCarthy
Head of Corporate Development
[email protected]

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This means that the charging infrastructure is being continuously expanded and adapted to meet growing demand. The aim is to reduce emissions and contribute to more sustainable mobility – both in the corporate context and in the everyday working lives of employees.

Electromobility as a contribution to reducing emissions
Since 2024, the HENSOLDT Group has been recording greenhouse gas emissions along the entire value chain, known as Scope 3 emissions. These include emissions from business travel and daily commuting. The expansion of the charging infrastructure for electric vehicles is an important lever for reducing these emissions in the long term.

Steadily increasing use since 2021
The trend towards electric mobility is clear: since the first charging stations were installed in 2021, the amount of energy consumed has risen steadily – from around 30 MWh to 315 MWh in 2025. This development underlines the increasing acceptance of electric vehicles among HENSOLDT employees and confirms that HENSOLDT is on the right track.

Charging is carried out exclusively with industrial electricity from 100% renewable energies. We thus offer our employees a sustainable and attractive addition to charging at home or at public charging points.

Working together towards sustainable mobility
The continuous expansion of the charging infrastructure shows that electric mobility is firmly established at HENSOLDT. HENSOLDT welcomes the increasing use of electric vehicles and thanks all employees who are actively contributing to reducing emissions by switching to electric mobility.

Introduction

Vitiligo is a common autoimmune pigmentary disorder characterized by well-defined depigmented patches affecting the skin and mucous membranes. It can occur at any age, with a global prevalence of approximately 0.5%–1%.¹ Based on clinical manifestations, vitiligo is classified into four major types: segmental vitiligo (SV), non-segmental vitiligo (NSV), mixed vitiligo, and indeterminate vitiligo. NSV encompasses several subtypes, including disseminated, generalized, facial–cervical, acral, and mucosal forms. Disease progression is commonly divided into active and stable phases.² Childhood vitiligo (CV) is defined as vitiligo with onset before the age of 12 years and accounts for approximately 32–40% of all vitiligo cases.³ The epidemiology, clinical characteristics, associated comorbidities, and therapeutic strategies of CV differ significantly from those of adult-onset vitiligo. Previous studies have shown that children with NSV are at increased risk of developing other autoimmune-related conditions, particularly thyroid disorders, allergic diseases, and atopic dermatitis.⁴ Although vitiligo does not affect life expectancy, its pronounced cosmetic impact should not be underestimated. In modern family structures, where children often play a central role, vitiligo can substantially affect a child’s physical development, psychological well-being, self-esteem, and quality of life.⁵ Moreover, the disease exerts a considerable psychosocial burden on family members, significantly influencing their social interactions and emotional health.⁶

Topical corticosteroids, topical calcineurin inhibitors, and narrowband UVB (NB-UVB) are the most commonly used and safe treatments for CV.⁷ While topical corticosteroids (TCS) are effective in the treatment of CV, their long-term use—particularly of high-potency formulations—is associated with an increased risk of local adverse effects, including cutaneous atrophy, telangiectasia, and hypertrichosis, as well as potential systemic effects such as growth suppression and hypothalamic–pituitary–adrenal axis dysfunction. Pimecrolimus cream, a topical calcineurin inhibitor, improves vitiligo by suppressing inflammatory cytokine release and reducing antigen-presenting cell activity.⁸ This cream demonstrates comparable efficacy to TCS without its adverse effects,⁹ offering promising prospects for CV treatment.

Crisaborole ointment is a phosphodiesterase-4 (PDE-4) inhibitor.¹⁰ PDE-4 inhibition leads to activation of the cyclic adenosine monophosphate (cAMP) signaling pathway, thereby suppressing Th1-mediated immune responses and interleukin-17 (IL-17)–producing T helper cells, resulting in anti-inflammatory effects. In addition, activation of the cAMP pathway promotes melanogenesis and stimulates melanocyte proliferation and differentiation.^11,12 Based on these biological mechanisms, several studies have demonstrated the therapeutic potential of crisaborole in the treatment of vitiligo.^13,14

Currently available phototherapy modalities for vitiligo include ultraviolet A (UVA), psoralen plus UVA (PUVA), ultraviolet B (UVB), narrowband UVB (NB-UVB), and 308-nm excimer light. Among these, 308-nm excimer light allows for precise, targeted irradiation of vitiligo lesions, offering distinct advantages such as high therapeutic efficacy, rapid clinical response, and minimal exposure of surrounding healthy skin. The therapeutic effects of phototherapy are primarily mediated through suppression of local lymphocyte proliferation, reduction of pro-inflammatory cytokine production, modulation of aberrant immune responses, and subsequent improvement of depigmented lesions.¹⁵ Moreover, studies have demonstrated that 308-nm excimer laser irradiation induces a greater accumulation of cyclobutane pyrimidine dimers (CPDs) within the deeper regions of hair follicles, while simultaneously accelerating CPD clearance in the epidermis and reducing keratinocyte apoptosis, thereby effectively activating melanocyte lineage cells.¹⁶ In a NB-UVB phototherapy study, no statistically significant differences were observed between pediatric and adult patients with respect to treatment dose, duration, or total number of sessions. Notably, children exhibited a lower incidence of adverse reactions, further supporting the safety and effectiveness of phototherapy in the management of pediatric vitiligo.¹⁷

Multiple studies have demonstrated that the combination of phototherapy with topical pharmacologic agents significantly enhances local treatment efficacy while maintaining a favorable safety profile.^18–20 Based on the above evidence, pimecrolimus cream, crisaborole ointment, and 308-nm excimer laser therapy each demonstrate therapeutic efficacy in vitiligo. It is therefore hypothesized that their combined application may achieve superior clinical outcomes compared with monotherapy. However, current clinical data on the efficacy and safety of crisaborole ointment combined with pimecrolimus cream in non-segmental CV remain limited. Therefore, this retrospective study aimed to evaluate the efficacy, safety, repigmentation patterns, and adverse reactions of combining these two topical agents with 308-nm excimer light in patients with non-segmental CV treated at our hospital.

Materials and Methods

Clinical Data

This study retrospectively included 120 children with NSV who visited the Department of Dermatology at the Second Affiliated Hospital of Wenzhou Medical University, China from January 2023 to December 2023. The study complies with the Declaration of Helsinki and was approved by the Ethics Committees of the Second Affiliated Hospital of Wenzhou Medical University and Yuying Children’s Hospital (2025-K-23-02). The guardians of all enrolled children provided written informed consent for the use of treatment-related images and clinical data for medical research and publication, with appropriate measures implemented to ensure patient privacy and data confidentiality. All patients underwent standardized pre-treatment photographic documentation, including natural-light photography and Wood’s lamp examination in a darkroom, as well as dermoscopic evaluation. Baseline clinical information, including age, age at disease onset, primary clinical manifestations, lesion distribution, disease activity, and prior treatment history, was systematically collected to characterize patient profiles (Figures 1 and 2).

Figure 1 Non-segmental CV patients. (A–D) Face & Neck. (E–F) Trunk. (G) Extremities. (H) Acral limbs.

Figure 2 Technical roadmap.

Inclusion Criteria: 1. Meets the diagnostic criteria for NSV in the 2021 Consensus on Vitiligo Diagnosis and Treatment,² with a lesion area less than 10%; 2. Age between 2 and 12 years; 3. Completed at least 12 weeks ofregular treatment (or fewer than 12 treatment sessions but has achieved remission); 4. No other systemic treatments received within one month prior to treatment.

Exclusion Criteria: 1. Patients who completed fewer than 12 treatment sessions, requested discontinuation during the study, or had incomplete clinical data documentation; 2. Patients with concomitant severe medical conditions; 3. Patients taking immunosuppressants or other photosensitizing medications.

Clinical staging based on the Vitiligo Disease Activity (VIDA):²¹ 1. New onset within the past 6 weeks: score 4; 2. New onset within the past 3 months: score 3; 3. New onset within the past 6 months: score 2; 4. Onset within the past year: score 1; 5. Stable for at least 1 year: score 0; 6. Stable for at least 1 year with spontaneous repigmentation: score −1. A score >1 indicates active disease, while scores ≤1 indicate stable disease. A total of 96 cases were classified as active disease, and 24 cases as stable disease. Skin phototypes were determined according to the Fitzpatrick classification.²²

Methods

Primary Instruments

308-nm Excimer Ultraviolet Light Therapy Device (Chongqing Demar Optoelectronic Technology Co., Ltd), Dermoscopy Image Processing Workstation (Beijing Demate Jiekang Technology Development Co., Ltd), and NR10QC Color Difference Meter (Sanenshi, Shenzhen, China).

Groups

Groups were assigned as follows: Group 1 received 308-nm excimer light combined with pimecrolimus cream (Ainingda, MEDA Manufacturing, 1% concentration); Group 2 received 308-nm excimer light combined with crisaborole ointment (Sutameng, Pharmacia and Upjohn Company LLC, 2% concentration); Group 3 received 308-nm excimer light alone (control group).

308-nm Excimer Light Treatment

Irradiation was administered once weekly. Prior to the first treatment session, the MED was determined on the abdominal skin. Erythema at the test site was evaluated 24 hours after irradiation, and the MED was established based on the erythema response duration. Following the initial irradiation, the erythema response of the treated vitiligo lesions was carefully monitored. Subsequent irradiation doses were adjusted according to the following criteria: if no erythema occurred or if erythema resolved within 24 hours, the previous dose was increased by 50 mJ/cm²; if erythema resolved between 24 and 48 hours, the dose was maintained for the next session; and if erythema persisted for more than 48 hours, or if marked erythema or blistering developed, treatment was temporarily suspended until complete resolution of the reaction, after which irradiation was resumed at an adjusted dose. During treatment, customized light shields were trimmed to conform to the shape of each child’s vitiligo lesions, thereby protecting adjacent uninvolved skin. The treatment head was maintained in close contact with the lesion surface throughout irradiation to ensure uniform and accurate energy delivery.

Topical Medication Use

Topical medication was discontinued on the day of 308-nm excimer light therapy. If no clinically significant adverse reactions occurred, medication was resumed the following day and applied twice daily. In the event of adverse reactions, such as blistering or burning pain, medication was withheld until symptom resolution or substantial improvement, after which it was reinitiated.

Efficacy Evaluation and Depigmentation Pattern Assessment Method

Evaluation of Treatment Efficacy for Vitiligo: Efficacy evaluations were conducted at 4 weeks, 8 weeks, and 12 weeks post-treatment. Photographs of the pediatric patient’s vitiligo lesions were taken under a Wood’s lamp in a darkroom. Additionally, photographs were taken with a steel ruler (minimum scale of 1 mm) placed around the lesions as a reference scale. ImageJ was used to assess changes in lesion area. Images with the steel ruler were imported into ImageJ. The ruler scale was set using the Line tool, and the Freehand Selection tool was used to outline the lesion boundaries. The required areas were measured (pre-treatment area denoted as S0; areas at 4 weeks, 8 weeks, and 12 weeks denoted as S1, S2, and S3, respectively) (Figure 3). Percentage reduction in lesion area was calculated as: (S0-S1)/S0 × 100%, (S0-S2)/S0 × 100%, (S0-S3)/S0 × 100%, rounded to one decimal place. Specific efficacy criteria based on vitiligo changes and (S0-S3)/S0×100% values: 1. Ineffective: Enlarged vitiligo area or no repigmentation. 2. Minimally effective: Partial reduction in vitiligo area or appearance of brownish-dark spots (<50%). 3. Beneficial: 50–95% (inclusive of 50%, exclusive of 95%) reduction in affected area. 4. Remarkable: the total disappearance of the affected area or a reduction of ≥95%. Efficacy rate = (Remarkable + Beneficial) / Total cases × 100%.

Figure 3 Outlining lesion perimeters using ImageJ.

Color Difference Meter for Evaluating Color Changes in Vitiligo Lesions: Pre-treatment, the color difference meter measures the difference in red-green axis values (ΔL*) between the vitiligo lesion surface and surrounding normal skin (or symmetrical areas), denoted as ΔL*0 (randomly select 4 points each from the vitiligo lesion and normal skin, calculate the average, rounded to one decimal place). At 4 weeks, 8 weeks, and 12 weeks post-treatment, measurements are taken using the same method to obtain ΔL*1, ΔL*2, and ΔL*3. Color changes before and after treatment are expressed as percentage of color fading: (ΔL*0 – ΔL*1) / ΔL*0 × 100%, (ΔL*0 – ΔL*2) / ΔL*0 × 100%, (ΔL*0 – ΔL*3) / ΔL*0 × 100%, each rounded to one decimal place. Specific efficacy assessment criteria based on the values of (ΔL*0 – ΔL*3) / ΔL*0 × 100% and lesion changes: 1. Ineffective: ≤0% or enlargement of depigmented area; 2. Minimally effective: Between 0% and 50% (excluding 0% and 50%); 3. Beneficial: 50–95% (includes 50%, excludes 95%). 4. Remarkable: ≥95%. Efficacy rate = (Remarkable + Beneficial)/ Total cases × 100%.

Criteria for Determining Repigmentation Pattern: Researchers visually examine and utilize dermatoscopy to observe repigmentation patterns. Patterns are categorized as follows:

1. Perifollicular type: Pigmented islands centered around hair follicles appear within the depigmented area; 2. Marginal type: The edges of the depigmented area begin to contract, gradually shrinking in size while pigmentation develops toward the center; 3. Diffuse type: The entire depigmented area regains uniform color without distinct pigmented islands or bands; 4. Hybrid type: Any combination of two or more of the preceding three repigmentation patterns. Pigmentation at the periphery of the lesion spreads toward the center while central pigment islands also expand outward (Figure 4).

Figure 4 Four repigmentation patterns in vitiligo. (A) Perifollicular. (B) Marginal. (C) Diffuse. (D) Hybrid.

Statistical Methods

Statistical analysis was performed using SPSS version 26.0 for Windows. Quantitative data are expressed as mean ± standard deviation (x ± s). Intergroup comparisons were conducted using analysis of variance. Qualitative data are presented as case numbers (n) and percentages (%). Intergroup comparisons were performed using the chi-square (χ²) test. A P-value < 0.05 was considered statistically significant. For pairwise comparisons among the three groups, the Bonferroni correction was applied to adjust P-values. The adjusted significance level was set at P=0.05/3=0.0167, with P<0.0167 indicating statistically significant differences.

Results

Clinical Efficacy (Response Rate) Observation Comparison

A total of 120 pediatric patients were enrolled. Group 1 comprised 39 patients, including 20 males and 19 females, with a mean age of (7.02 ± 2.43) years and a mean disease duration of (6.33 ± 2.75) months. A total of 82 skin lesions were documented: 37 on the face and neck, 23 on the trunk, 17 on the extremities, and 5 on the acral limbs. Group 2 comprised 39 patients: 21 males and 18 females, with a mean age of (7.44 ± 2.57) years and mean disease duration of (6.54 ± 2.68) months. A total of 78 lesions were recorded: 33 on the face and neck, 26 on the trunk, 15 on the extremities, and 4 on the acral limbs. The control group comprised 42 pediatric patients: 21 males and 21 females. The mean age was (7.26 ± 2.62) years, with a mean disease duration of (6.14 ± 2.93) months. A total of 84 lesions were observed: 38 on the face and neck, 26 on the trunk, 14 on the extremities, and 6 on the acral limbs (Table 1). There was no statistically significant difference between the three groups regarding gender, age, disease duration, number and distribution of lesions, and disease activity (P > 0.05).

Table 1 Patient Baseline Characteristics

After 4 weeks of treatment, the response rates for Group 1, Group 2, and the control group were 34.1%, 32.1%, and 23.8%, respectively, with no statistically significant difference observed (P > 0.05). After 8 weeks of treatment, the response rates increased to 63.4%, 60.2%, and 42.8%, respectively, demonstrating a statistically significant difference among groups (P < 0.05). Following 12 weeks of treatment, the response rates for Group 1, Group 2, and the control group further increased to 76.8%, 71.7%, and 54.8%, respectively, with statistically significant differences maintained (P < 0.05) (Table 2 and Figure 5). Additionally, we conducted pairwise comparisons among the three groups. After 8 weeks of treatment, the difference between the Group 1 and the control group was statistically significant. (P < 0.0167). No statistically significant difference was observed between Group 2 and the control group (P > 0.0167), nor between Group 1 and Group 2 (P > 0.0167). After 12 weeks of treatment, the difference between Group 1 and the control group was statistically significant (P < 0.0167). The difference between Group 2 and the control group was not statistically significant (P > 0.0167). The difference between Group 1 and Group 2 was not statistically significant (P > 0.0167). The results indicate that both pimecrolimus cream and crisaborole ointment combined with phototherapy demonstrated higher efficacy rates than phototherapy alone. Although Group 1 consistently showed higher efficacy rates than Group 2 throughout the entire treatment period, the difference in efficacy between Groups 1 and 2 was not statistically significant.

Table 2 The Therapeutic Effects of the Three Groups of Patients Were Compared After 4, 8 and 12 Weeks of Treatment

Figure 5 Lesion presentation in a pediatric NSV case deemed treatment-responsive. (A–D) Pre-treatment (Week 0). (A) Under natural light. (B) Wood’s lamp. (C and D) Dermatoscopy. (E–H) Week 4 of treatment. (E) Under natural light. (F) Wood’s lamp. (G and H) Dermatoscopy. (I-L) Week 8 of treatment. (I) Under natural light. (J) Wood’s lamp. (K and L) Dermatoscopy. (M–P) Week 12 of treatment. (M) Under natural light. (N) Wood’s lamp. (O and P) Dermatoscopy.

Comparison of Clinical Adverse Reaction Rates

Adverse reactions were monitored throughout the treatment period. In Group 1, a total of 82 lesions were treated, of which 13 lesions developed pruritus, 5 lesions experienced burning pain, and 6 lesions developed blisters, resulting in an overall adverse reaction rate of 29.3%. In Group 2, 78 lesions were evaluated; among these, 11 lesions developed pruritus, 11 lesions experienced burning pain, and 5 lesions developed vesicles, corresponding to an adverse reaction rate of 34.6%. In the control group, 84 lesions were treated, with 9 lesions developing pruritus, 3 lesions experiencing burning pain, and 4 lesions developing blisters, yielding an adverse reaction rate of 19.0%. Patients who developed blisters temporarily discontinued topical medication and resumed treatment after complete resolution of the lesions. All other adverse reactions were mild, well tolerated, and resolved spontaneously within 24–48 hours. Although the incidence of adverse reactions was highest in Group 2, followed by Group 1 and the control group, the differences among the three groups were not statistically significant (P > 0.05) (Table 3).

Table 3 Comparison of Adverse Reaction Rates Among the Three Groups of Patients [n,(%)]

Comparative Analysis of Recoloring Modes for Different Body Parts

A total of 108 lesions were identified on the face and neck, with repigmentation patterns distributed as follows: 45 marginal, 32 perifollicular, 19 diffuse, and 12 hybrid. The trunk region comprised 75 lesions, with 18 marginal, 34 perifollicular, 10 diffuse, and 13 hybrid patterns observed. On the extremities, 46 lesions were documented, including 8 marginal, 22 perifollicular, 6 diffuse, and 10 hybrid patterns. The acral limbs exhibited 15 lesions, with 9 marginal, 1 perifollicular, 2 diffuse, and 3 hybrid patterns (Table 4). The results indicated that the marginal repigmentation pattern predominated in the face and neck, followed by the perifollicular pattern, whereas diffuse and hybrid patterns were less frequently observed. In the trunk and extremities, the perifollicular pattern was the most prevalent, followed by marginal, hybrid, and diffuse patterns. In the acral limbs, the marginal pattern was the most common, while perifollicular, hybrid, and diffuse patterns occurred less frequently. Statistically significant differences in repigmentation patterns were observed among different anatomical regions, including the face/neck, trunk, extremities, and acral areas (P < 0.05). In contrast, no statistically significant differences in repigmentation patterns were detected among the three treatment groups (P > 0.05). Additionally, during the repigmentation process, peripheral skin pigmentation within treated lesions frequently became darker than the surrounding normal skin in exposed areas across all pediatric patients.

Table 4 Comparative Analysis of Repigmentation Patterns in Different Parts [n,(%)]

Comparative Analysis of Clinical Efficacy Across Different Body Regions

After 12 weeks of treatment, the face and neck region comprised 108 lesions, including 17 Minimally effective, 46 Beneficial, and 45 Remarkable cases, yielding an overall efficacy rate of 84.2%. The trunk included 75 lesions, of which 25 were Minimally effective, 43 were Beneficial, and 7 were Remarkable, resulting in an efficacy rate of 66.7%. The extremities presented 46 lesions, with 26 Minimally effective, 18 Beneficial, and 2 Remarkable, corresponding to an efficacy rate of 43.4%. The acral limbs comprised 15 lesions, including 11 Minimally effective and 4 Beneficial cases, with an efficacy rate of 26.7%. Overall, treatment efficacy differed significantly among anatomical regions, following the order: face and neck > trunk > extremities > acral limbs. Statistically significant differences in clinical efficacy were observed across different body regions (P < 0.05) (Table 5).

Table 5 Comparison of the Therapeutic Effects of Skin Lesions in Different Parts [n,(%)]

Univariate and Multivariate Logistic Regression Analysis of 8-Week Therapeutic Effect

As shown in Table 6, univariate analysis demonstrated that sex, disease activity, and treatment modality were significantly associated with therapeutic response. After variables with P < 0.05 were entered into the multivariate analysis, disease activity (OR = 2.698, P = 0.003), Group 1 (OR = 2.645, P = 0.004), Group 2 (OR = 2.265, P = 0.015), and sex (OR = 0.563, P = 0.038) remained independently and significantly associated with treatment efficacy.

Table 6 Univariate and Multivariate Analyses Related to 8-Week Treatment

Univariate and Multivariate Logistic Regression Analysis of 12-Week Therapeutic Effect

As shown in Table 7, univariate analysis indicated that sex, disease activity, Fitzpatrick skin classification, and treatment modality were significantly associated with therapeutic response. After variables with P < 0.05 were included in the multivariate analysis, disease activity (OR = 2.570, P = 0.005), Group 1 (OR = 3.137, P = 0.001), and Group 2 (OR = 2.400, P = 0.013) remained independently and significantly associated with treatment efficacy.

Table 7 Univariate and Multivariate Analyses Related to 12-Week Treatment

Discussion

This retrospective study evaluated the therapeutic efficacy of different treatment modalities in 120 pediatric patients with NSV. At present, clinical assessment of repigmentation in vitiligo largely depends on physicians’ visual estimation of depigmented lesion size, which, although rapid, convenient, and cost-effective, is subjective and limited by interobserver variability. In contrast, the present study employed a comprehensive evaluation strategy integrating dermatoscopy, ImageJ analysis, Wood’s lamp examination, and a color difference meter to assess treatment outcomes. Compared with conventional methods such as color extraction using Photoshop or manual grid-based area calculation, this multimodal assessment approach is more efficient and practical. Moreover, it enables continuous, standardized, and fully documented data acquisition throughout the treatment course, thereby enhancing objectivity, reproducibility, and clinical applicability in vitiligo research.

With the assistance of dermatoscopy, this study observed and statistically analyzed the repigmentation patterns in vitiligo patients. Significant differences were noted in repigmentation patterns and clinical efficacy across different body regions. Previous studies have reported that repigmentation in vitiligo typically initiates at hair follicle openings and spreads peripherally, whereas hairless, smooth skin areas are difficult to repigment.²³ This observation was further supported by the subsequent discovery of follicular melanocyte stem cells, a reservoir of melanocytes and their niche located in the lower permanent hair follicle, which explains the greater repigmentation potential in hair-rich areas.²⁴ Marginal repigmentation refers to the contraction of depigmented areas from the periphery toward the center, potentially mediated by the presence of functional melanocyte pools within the epidermis at the lesion margins.²³ Diffuse repigmentation, characterized by uniform color restoration across the entire vitiligo patch, may involve melanocyte precursors between dermal follicles or epidermal melanocytes reactivated via dopa metabolism within the follicular space, both of which reside at the center of vitiligo lesions.²⁵ Based on these distinct repigmentation patterns, this study employs dermatoscopy as an examination tool to magnify lesions, enabling further observation of lesion distribution and changes. This facilitates improved assessment and prediction of treatment efficacy.

ImageJ has been widely applied in evaluating the efficacy of vitiligo treatments.²⁶ In this study, for patients with repigmentation patterns classified as marginal, perifollicular, or hybrid, we manually selected the affected areas under Wood’s lamp illumination to measure their sizes. The reduction in vitiligo patch areas was digitally recorded, a method recognized for its accuracy and stability.²⁷ However, for vitiligo patients with diffuse repigmentation patterns, relying solely on area changes to assess treatment efficacy is inaccurate. Previous studies have found that color changes precede area reduction in patients with diffuse repigmentation.²⁸ Therefore, we additionally employed a color difference meter to precisely evaluate disease progression and treatment response, thereby guiding subsequent therapeutic strategies.

At present, a wide range of therapeutic options are available for vitiligo; however, treatment efficacy varies considerably among pediatric patients. For patients with CV, both safety and therapeutic effectiveness are critical considerations in treatment selection.³ The 308-nm excimer light is a high-energy, targeted phototherapy modality derived from narrowband ultraviolet light, offering distinct advantages including strong tissue penetration, high lesion selectivity, and precise localized treatment. Adverse reactions associated with this therapy are generally mild and transient, most commonly including erythema, pruritus, and skin dryness. Importantly, 308-nm excimer light therapy provides an additional practical advantage in pediatric patients, as children are not required to enter the relatively enclosed NB-UVB cabinet, thereby reducing treatment-related anxiety, fear, and feelings of isolation. Accordingly, 308-nm excimer light was selected as the baseline control treatment modality for CV in the present study.

In this study, the efficacy rates of 308-nm excimer light combined with pimecrolimus cream and crisaborole ointment were 76.8% and 71.7%, respectively, whereas the efficacy rate of 308-nm excimer light monotherapy was 54.8%. Both combination therapy groups demonstrated significantly superior therapeutic efficacy compared with the monotherapy group. Previous studies by Jiang et al have reported that combination therapy yields better clinical outcomes than monotherapy, and the findings of the present study are consistent with these results.²⁹ Additionally, regarding treatment sites, efficacy was observed in the following descending order: face, neck, trunk, extremities, and acral limbs. This finding is consistent with previous studies.^30,31 Previous studies have also confirmed this point. It is believed that areas with higher hair follicle density (face and neck, limbs, trunk) respond more quickly to treatment, while areas with lower hair follicle density (back of hands and feet) respond more slowly to treatment. Depigmented areas with absent or low-density hair follicles (palms, soles) rarely respond to treatment.³⁰

Furthermore, through logistic regression analysis, we found that children in the active disease were more likely to achieve effective outcomes. Previous studies have shown that for progressive vitiligo, early and active treatment is necessary to reduce irreversible damage to melanocytes. For stable vitiligo, treatment is needed to promote the proliferation and differentiation of melanocyte precursor cells in hair follicles or interfollicular areas to achieve pigment recovery.^32,33 In this study, children in the active disease had a shorter disease duration than those in the stable disease, and their hair follicle melanocytes were not completely destroyed, thus they could achieve better outcomes.

Regarding adverse reactions, the most common side effect reported by patients using pimecrolimus cream was itching. During subsequent treatment, patients gradually adapted, experiencing almost no discomfort in later treatment sessions. In contrast, the most frequently reported adverse reactions for crisaborole cream were burning pain and itching, consistent with our clinical experience using this medication to treat pediatric atopic dermatitis patients. However, symptoms in pediatric patients were generally mild. Similarly, as patients adapted to the medication, these adverse reactions gradually diminished or resolved. During 308-nm excimer light therapy, the primary adverse reactions were itching and blistering. Itching was mostly transient, correlated with the duration of erythema, and improved as the erythema subsided. Blistering often resulted from too rapid an increase in light energy. Skin tolerance varies among patients. When adjusting irradiation energy, increasing exposure duration may inadvertently elevate energy levels excessively, potentially causing erythema and blisters persisting beyond 48 hours. This underscores the need for careful, gradual energy adjustments rather than hasty modifications.

This study also has certain limitations. This study did not conduct a power calculation, which may have resulted in a relatively small sample size. Additionally, the retrospective study period was not lengthy, thus presenting inherent limitations. Therefore, the results are hypothesis-generating rather than definitive evidence forpractice-changing recommendations. Second, due to the school-age characteristics of CV patients, the treatment frequency of once weekly with 308-nm excimer light was relatively low, which may have impacted efficacy. Third, retrospective studies are subject to selection bias and recall bias, necessitating prospective studies to validate these observations. Consequently, further research with larger population samples and more comprehensive data is required to clarify these findings and conduct more in-depth investigations. Fourth, this study employed telephone and outpatient follow-up methods, and the lack of statistical data on compliance represents one limitation of this experiment.

In summary, this study investigated the efficacy and safety of 308-nm excimer light combined with pimecrolimus cream and crisaborole ointment for treating non-segmental CV in pediatric patients. This approach enhances treatment efficacy with favorable safety profiles, mild adverse reactions that resolve rapidly with timely symptomatic management, and no significant systemic side effects. Given the multifaceted pathogenesis of vitiligo, novel targeted therapies continue to emerge as new mechanisms are elucidated. We must persist in exploration and advancement to discover more effective treatment strategies for this condition.

Conclusion

With increasing treatment duration, both the effective rate and repigmentation area of vitiligo lesions progressively increase. Combination therapy using 308-nm excimer light together with pimecrolimus cream and crisaborole ointment demonstrates favorable clinical efficacy in pediatric vitiligo, significantly improving both repigmentation rates and overall treatment effectiveness. Although the incidence of adverse reactions is higher with combination therapy, these events are predominantly mild, transient, and not associated with significant systemic adverse effects, indicating a favorable safety profile. Clinical efficacy varies among different anatomical regions, with response rates decreasing in the following order: face and neck > trunk > extremities > acral limbs. Repigmentation patterns also differ across these regions, reflecting distinct regional biological responses. The integrated use of dermatoscopy, a color difference meter, Wood’s lamp examination, and ImageJ analysis enables convenient, objective, and accurate digital documentation of changes in lesion color and area before and after treatment. Notably, in cases of diffuse repigmentation, alterations in pigmentation intensity precede measurable reductions in lesion area, allowing more sensitive evaluation of therapeutic response and facilitating optimization of subsequent treatment strategies.

Abbreviations

SV, segmental vitiligo; NSV, non-segmental vitiligo; CV, childhood vitiligo; TCS, topical corticosteroids; PDE-4, phosphodiesterase-4; cAMP, cyclic adenosine monophosphate; VIDA, Vitiligo Disease Activity; MED, minimal erythema dose.

Disclosure

The authors report no conflicts of interest in this work.

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Key areas to watch

In addition to headline revenue and EPS figures, investors will focus on several key areas during Palantir’s Q4 2025 earnings report.

Continued AIP and US commercial momentum

Investors will watch for sustained triple-digit US commercial growth, new AI Platform (AIP) bootcamps/deals, and customer additions. Expansion in commercial (now approximately 30% – 40% of revenue) is key to diversifying beyond government.

Government segment and contracts

Updates on US government deals, potential international acceleration, and any risks from government funding/shutdown scenarios.

Profitability and margins

Track adjusted operating margins, free cash flow delivery toward the $1.9 billion – $2.1 billion full year guide. Rule of 40 score remains a flagship metric – expect commentary on maintaining 100%+.

Forward guidance

Focus on forward 2026 guidance, as any softening combined with lofty valuations could trigger volatility.

Broader AI/competitive landscape

Any mentions of AIP leverage vs competitors, enterprise adoption trends, or macro headwinds.

Is Palantir a buy or a sell?

Palantir has a TipRanks Smart Score of ‘6 neutral’ and is rated as a ‘hold’ by analysts with 6 ‘buy’, 10 ‘hold’, and 12 ‘sell’ recommendations as of 27 January 2026.

Palantir TipRanks Smart Score chart