Clinical Research Directory

Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo

This study evaluates whether exosomes derived from human umbilical cord mesenchymal stem cells (hUMSCs-Exo) are safe and effective for treating vitiligo in adults. Vitiligo is a skin condition that causes white patches due to loss of pigment-producing cells. Current treatments have limitations, especially for patients with active disease who require oral steroids with significant side effects. This study is a single-center, randomized, controlled trial enrolling 96 adults aged 18 to 65 years with non-segmental vitiligo. Participants are divided into two groups based on disease activity: progressive vitiligo (new patches appearing or existing patches expanding in the past 3 months) and stable vitiligo (no changes in the past year). For progressive vitiligo, participants are randomly assigned to either: Experimental group: hUMSCs-Exo given by intravenous infusion every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: oral prednisone (a standard steroid treatment) plus tacrolimus ointment and narrowband UVB light therapy For stable vitiligo, participants are randomly assigned to either: Experimental group: hUMSCs-Exo given by local injection into the white patches every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: tacrolimus ointment plus narrowband UVB light therapy alone The treatment period lasts 12 weeks, with follow-up visits continuing to 24 weeks. The main outcome measures include improvement in skin repigmentation measured by the Vitiligo Area Scoring Index (VASI), changes in quality of life, and safety monitoring throughout the study. This study aims to establish a standardized approach for using hUMSCs-Exo in vitiligo treatment and to explore how exosomes may work by reducing oxidative stress and regulating immune responses.

Vitiligo Registry for Adults and Children in the UK

Vitiligo is the most common depigmentation disorder affecting around 1% of the population worldwide. Fifty two percent of patients develop vitiligo before the age of 20 and around 80% develop vitiligo before the age of 30 years old.1 Vitiligo often presents in childhood and tends to be a lifelong disease, requiring prolonged courses of phototherapy. Currently no national or international registry for patients with vitiligo exists. Individual dermatologists maintain a database of such patients, however no coordinated efforts have been made to combine these individual registries into a broader national registry. Finally, recently published British Association of Dermatologists (BAD) guideline for the management of vitiligo, recommended the development of a national registry for people with vitiligo undergoing systemic or light therapy to identify outcomes and safety.

Comparative Efficacy of hUCMSC-Secretome Delivered Via Microneedling and Intradermal Microinjection as Adjuvant Therapy to NB-UVB in Nonsegmental Vitiligo: A Quasi-Experimental Study

The goal of this clinical trial is to analyze the effectiveness of SM-hUCMSC secretome administered via microneedling and intradermal microinjection as adjuvant therapy to NB-UVB, compared with NB-UVB alone, in terms of repigmentation, onset of improvement, safety, patient satisfaction, and vitiligo recurrence. The main questions it aims to answer are: * Are there differences in the level of vitiligo lesion repigmentation among the secretome therapy via microneedling, intradermal microinjection, and NB-UVB phototherapy groups? * Are there differences in the time to onset of repigmentation among the treatment groups? What are the safety profiles and adverse events associated with each treatment modality? * Are there differences in patient satisfaction and quality of life after undergoing each therapy? * Are there differences in vitiligo recurrence rates during the follow-up period among the treatment groups? Participants will be allocated into three groups as follows: * Group A receives NB-UVB combined with microneedling and topical 10% secretome. * Group B receives NB-UVB combined with intradermal secretome injection. * Group C receives NB-UVB alone. The intervention period lasts 12 weeks, with follow-up until week 24.

A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC

TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Combination Approach With Ritlecitinib and nbUVB Compared to Ritlecitinib Alone for Treating Vitiligo

Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. areas of high stress. Ritlecitinib, an orally administered inhibitor of JAK3 (Janus kinase)/ TEC (tyrosine kinase expressed in hepatocellular carcinoma) has shown effectiveness and safety for the treatment of vitiligo. In a phase 2b trial, three doses of ritlecitinib, 200/50 mg, 100/50 mg, and 50 mg, were all statistically significant versus placebo on the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 in patients with active NSV. Considering that the immune process primarily contributes to depigmentation while ultraviolet (UV) radiation stimulates the differentiation and proliferation of melanocyte stem cells for re-pigmentation, the investigators propose that a combination therapy using ritlecitinib and narrowband UVB (nbUVB) could offer an optimal approach for treating vitiligo patients. The primary objective is thTo compare between the groups, the mean percentage change from baseline in F-VASI and T-VASI at week 52. Following central randomization, patients will be assigned to receive either ritlecitinib 100mg daily (QD) or a combined therapy using ritlecitinib 100mg QD + twice weekly narrowband UVB treatment for a duration of 52 weeks. At the end of this period, all participants will continue for the open-label phase, receiving ritlecitinib 100mg QD. Eligible participants will be stratified by Fitzpatrick Skin Type (FST, also known as phototype). More specifically, there will be 2 strata based on FST targets: (1) FST I to III (2) FST I IV, to VI. Each FST stratum will target to enroll at least 50% participants into the study population. Stratified randomization across FST sub-groups will support the evaluation of a consistent benefit-risk profile across all FST strata. Enrollment of participants with active or stable nonsegmental vitiligo will be proactively managed without formally capping or stratifying. Throughout the study, there will be a total of 8 visits conducted: selection, inclusion, week 4, week 12, week 24, week 36, week 52 and week 72. In patients who volunteer, a skin biopsy will be performed on both the lesional and perilesional areas at baseline, week 4 and week 52. We aim to include between 12 and 20 volunteer patients. Serum and plasma samples will be collected at the screening visit, week 4, week 12, week 24, week 36, week 52 and week 72. A pregnancy test will be performed every 4 weeks i.e. at weeks 8, 16, 20, 28, 32, 40, 44, 48, 56, 60, 64 and 68;

The Value of Adding Mini-oral Pulse Steroid Therapy in Preventing Peri-lesional Halo Post Non-cultured Epidermal Cell Suspension (NCES) in Cases With Stable Segmental and Non-acral Vitiligo.

The goal of this clinical trial is to learn if adding mini-oral pulse steroid therapy improves the results of non-cultured epidermal cell suspension (NCES) surgery in patients with stable vitiligo. It will also evaluate the safety of this treatment approach. The main questions it aims to answer are: * Does adding mini-oral pulse steroid therapy reduce the development of a perilesional halo after NCES surgery? * Does the addition of steroids improve the degree of repigmentation and overall treatment outcomes in vitiligo lesions? Researchers will compare NCES surgery with mini-oral pulse steroids to NCES surgery alone to determine whether the steroid therapy improves surgical outcomes. Participants will: * Undergo NCES vitiligo surgery for stable segmental or non-acral vitiligo lesions. * Be randomly assigned to receive either surgery alone or surgery plus low-dose oral mini-pulse dexamethasone therapy. * Attend follow-up visits and clinical assessments for approximately 4 months. * Receive excimer laser sessions twice weekly after healing and have standardized photographs and scoring assessments to evaluate repigmentation.

Daily Topical Rapamycin for Vitiligo

In current Dermatology practice, options for vitiligo remain limited. The purpose of this study is to determine if once daily dosed topical rapamycin is effective for the treatment of patients with vitiligo. Participants will apply either 0.1% topical rapamycin or 0.001% topical rapamycin for six months to a lesion on one side of the body, and topical placebo to a corresponding lesion on the opposite side of the body. The study also aims to evaluate patient satisfaction and identify any adverse effects on these dosing regimens.

The Value of Methotrexate in NCES for Stable Vitiligo

The goal of this clinical trial is to learn if adding a six months course of Methotrexate would improve the results of non cultured epidermal suspension (NCES) in adult patients with acral and resistant vitiligo lesions over the elbows and knees. researchers will compare results of NCES in two groups one group will receive Methotrexate for 3 months prior to the procedure and 3 months after the procedure, while the other group will not receive the drug. Patients will receive PUVA hand \& feet 3 times/week for 3 months after NCES during this period they will be followed up monthly to evaluate repigmentation.

Oral Mini Pulse Dexamethasone in Pediatric Vitiligo

The goal of this clinical trial is to learn if oral mini pulse (OMP) dexamethasone works to treat active vitiligo in children and also learn about the safety of this drug within this age group the main questions it aims to answer are does OMP halt activity in active vitiligo and what medical problems patients might experience while using the drug with special attention to linear growth. Researchers will give OMP dexamethasone to participating patients to see if the drug works to treat active vitiligo and whether it has any effect on linear growth. Participants will take OMP dexamethasone two fixed days per week for a period of 3 months. before starting treatment, patients will do baseline evaluation and investigations then monthly evaluation to monitor progress, report any side effects at the end of treatment period response to drug, lab values and growth will be evaluated then final evaluation of growth will be done after stoppage of drug.

Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo

The goal of this clinical trial is to learn how well 5 fluorouracil (5FU) with micro-needling works to treat limited vitiligo as compared to strong steroid applied on skin. It will also learn about the safety of both these treatments. The main questions it aims to answer are: * How well does 5FU with microneedling work to treat vitiligo by returning pigmentation in vitiligo patches as compared to steroid? * What is participant's satisfaction when treated with 5FU with microneedling as compared to steroid? * What skin problems do participants have when treated with FU with microneedling and steroid? Researchers will compare 5FU with microneedling to steroid application to see how well both work to return pigment in vitiligo patches. Participants will be divided into two groups. For Group A, 5 FU will be rubbed and absorbed on the vitiligo patch after micro-needling every 2 weeks. For group B, topical 0.05% clobetasol propionate ointment will be applied twice a day on the vitiligo patches for 12 weeks. Vitiligo patches will be assessed at the start of trial and then after 12 weeks of treatment.

A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo

The primary objective of the trial is to evaluate the safety of TEV-53408 administered subcutaneously for the treatment of adults with vitiligo. A secondary objective is to further evaluate the safety of TEV-53408. The planned study period per participant is 84 weeks including a screening period (up to 4 weeks), a 24-week open-label treatment period, a 16-week washout period, and a 40-week follow-up period.

A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo

The goal of this clinical trial is to learn if drug CGB-600 works to treat vitiligo on the face and neck in participants between 18-60 years of age. It will also learn about the safety of CGB-600. The main questions it aims to answer are: Does CGB-600 decrease the severity of vitiligo on the face and neck? What medical problems do participants have when taking drug CGB-600? Researchers will compare CGB-600 to a non-active drug (vehicle) to see if CGB-600 works to treat vitiligo. Participants will: Apply face twice daily for a period of 24 weeks. Visit the clinic 8 times for checkups and tests.

A Trial of SHR0302Base in Patients With Vitiligo

The purpose of this study is to evaluate the efficacy and safety of SHR0302Base in participants with nonsegmental vitiligo.

Nevus Removal vs. Conservative Treatment in Halo Nevus With Vitiligo: A Randomized Study

This clinical trial aims to compare the efficacy and safety of central nevus removal versus conservative treatment in patients with halo nevus accompanied by non-segmental vitiligo. It is a single-center, prospective, randomized controlled trial involving 60 participants aged 6 to 45 years, who will be randomly assigned to either the nevus removal group or the conservative treatment group. The removal group will undergo surgical or laser excision of the central nevus followed by medication, while the conservative group will receive medication only. Both groups will be followed for 6 months. Outcomes include repigmentation assessment using vitiligo scoring indices, quality of life measures, and serial serum cytokine profiling. The study seeks to provide high-level evidence to guide clinical management of halo nevus with vitiligo. Key points: 1. For patients with halo nevus accompanied by non-segmental vitiligo. 2. For patients aged 6 to 45 years. 3. Compares nevus excision and conservative treatment. 4. Follows participants for 6 months. 5. Focuses on effectiveness and safety.

LANDSCAPE: Demographics and Treatment Patterns of Patients With Immune-Mediated Inflammatory Skin Diseases in Italian Clinical Practice

This multicenter retrospective observational registry study will collect existing clinical data from Italian centers to describe epidemiology, treatment patterns, clinical evolution, safety, and comorbidities in patients aged 12 years and older with psoriasis, atopic dermatitis, vitiligo, alopecia areata, or hidradenitis suppurativa.

Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

A novel approach for 5-Fluorouracil delivery based on a solid effervescent formulation is proposed . 5-Fluorouracil is water soluble (\~50mg/ml) and therefore has been used for the development of novel topical formulations including nano and microparticles intended for skin targeting. After hydration 5-Fluorouracil could form a complex, a suspension or even be formulated to generate effervescence. In effervescent technology, gas bubbles occur from the liquid after chemical reaction between alkali salts and organic acids (mainly citric or tartaric. Due to liberation in CO2 gas, the dissolution of drug in water is enhanced. The aim of this study is the development and clinical evaluation of topical 5-florouracil effervescent powder formulation in the treatment of vitiligo.

A Real-world Study on the Influencing Factors of Efficacy of Ruxolitinib Cream in Vitiligo

Vitiligo is a common chronic autoimmune skin disease that can occur on any part of the body and severely impacts patients' quality of life. Current treatment for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgical interventions, but their efficacy is limited, often failing to achieve ideal therapeutic outcomes, and are associated with a high recurrence rate. This study is an investigator-initiated real-world research on the application of ruxolitinib cream for vitiligo treatment, with the primary objective of exploring the factors influencing the efficacy of ruxolitinib cream in treating vitiligo.

TRPM2 Gene Polymorphism, NLRP3 Inflammasome Expression in Vitiligo Patients

This study investigates the relationship between Transient Receptor Potential Melastatin 2 (TRPM2) gene polymorphism and Nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammasome expression in patients with vitiligo. Vitiligo is a common autoimmune depigmenting disorder characterized by melanocyte destruction associated with oxidative stress and immune dysregulation. TRPM2 is a calcium-permeable cation channel activated by oxidative stress, while NLRP3 inflammasome activation promotes inflammation through interleukin-1β (IL-1β) and interleukin-18 (IL-18) release. This study aims to evaluate TRPM2 genetic variants, NLRP3 expression levels, and their possible correlation with disease severity measured using the Vitiligo Area Scoring Index (VASI).

Building an Assessment Model for Vitiligo Activity and Prognosis Using Peripheral Blood Cytokine Profiles

Vitiligo is a chronic autoimmune disorder characterized by depigmented patches on the skin, which can pose significant psychosocial challenges, particularly for individuals with darker skin tones. Compared to the general population, individuals with vitiligo are more likely to experience immune-mediated diseases or psychological comorbidities. Studies confirm that the combined prevalence of depression and anxiety among vitiligo patients reaches 8% and 35.8%, respectively. Notably, the anxiety prevalence rate is comparable to that seen in other severely debilitating skin conditions such as eczema and psoriasis. However, the progression, stability, and recurrence of vitiligo exhibit high unpredictability. Unlike other inflammatory skin diseases such as psoriasis or atopic dermatitis, there is currently a lack of objective, sensitive biological markers in clinical practice to predict disease activity, forecast treatment response, or assess long-term prognosis. Decisions primarily rely on the attending physician's assessment of disease activity, affected areas, severity, and repigmentation potential. Furthermore, clinical signs of active vitiligo are only observable in some active-phase patients, introducing delays and subjectivity. This leads to reactive treatment decisions, increasing the likelihood of missing the optimal intervention window. Cytokines are small-molecule polypeptides or glycoproteins synthesized and secreted by the body's cells, possessing diverse biological activities. They play a central role in physiological and pathological processes such as immune regulation, anti-infection, and anti-tumor responses. The "Twelve Cytokine Panel" is a clinical test utilizing advanced flow cytometry for the combined analysis of 12 core cytokines. The cytokines included in this test are IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, IFN-α, IFN-γ, and TNF-α. This panel comprehensively reflects innate immune and T-cell immune responses, providing crucial laboratory evidence for evaluating the functional status of the immune system and inflammatory network. Cytokines serve as core messenger molecules in the autoimmune pathogenesis of vitiligo, forming a complex inflammatory network that governs the entire process of immune attacks against melanocytes. Consequently, detecting specific cytokine profiles not only deepens our understanding of vitiligo's disease mechanisms but also holds immense potential clinical value in assessing disease activity, monitoring treatment efficacy, and developing novel targeted therapies.

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo

This is a multi-center, parallel-group, open-label, randomized, Phase 1b study to explore the safety, clinical activity, pharmacokinetics and pharmacodynamics of DR-01 in adults with Alopecia Areata or Vitiligo.

Betamethasone Phonophoresis For Vitiligo

Vitiligo is a skin disorder that results in the formation of depigmented patches or hypopigmented macules due to selective destruction or reduction of melanocytes the cells that produce pigment in our skin. Vitiligo affects 0.1-2% of the World's population. People of all skin types and all ages can be affecte. In most of the cases, white patches develop or expand slowly overtime, and in some cases it never progress and remains stable . Vitiligo can be segmental or non-segmental depending upon the morphology of the clinical involvement. It can also be classified as stable or unstable based on the activity of disease. Steroids act as anti-inflammatory and immunosuppressant agents. Even if different classes of steroids are now available, the mid- potent ones (e.g. betamethasone dipropionate 0.05% cream, 0.05% clobetasol propionate ointment) are usually preferred for the treatment of young patients . Now days, topical corticosteroids are the most commonly prescribed agents in treatment of dermatologic conditions .Almost all treatments of vitiligo have borrowed from therapies whose prime targets have been another disease.

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo

A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.

A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (NSV). Adverse effects and change in disease activity will be assessed. Upadacitinib is an approved drug for various immune-mediated inflammatory diseases and is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B) and an optional exploratory Narrow-Band Ultraviolet B (NB-UVB) phototherapy study (Study 3). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo and 2 in 3 chance participants will receive upadacitinib. In Period B, all participants will receive upadacitinib. Approximately 270 adult and adolescent participants with NSV will be enrolled in each main study ((Study 1 and Study 2, 540 subjects total) at approximately 90 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI 90 at week 48 while on study drug, to enter Study 3. In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with NB-UBV phototherapy for at least 24 weeks followed by upadacitinib alone. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Autologous Non-cultured Epidermal Cell Suspension Transplantation in the Treatment of Vitiligo

To observe the long-term efficacy and safety of autologous non cultured epidermal cell suspension transplantation in the treatment of vitiligo, analyze the correlation between cell density, type, and postoperative efficacy and prognosis, and providing a basis for clinical application.