Trial · NCT07307534
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving VASl50 Response | From enrollment to the end of treatment at 6 months. | VASl (Vitiligo Area and Severity lndex) 50 response is defined as a 50% or greater reduction in VASl score from baseline. Assessment is conducted by trained dermatologists using standardized VASl scoring criteria. |
| Secondary | Percentage of Participants Achieving VASI75 and VASI90 responses at each follow-up time point | From enrollment to the end of treatment at 6 months. | VASl75 (or VASI90) response is defined as a 75% (or 90%) or greater reduction in VASl score from baseline. Assessment is conducted by trained dermatologists using standardized VASl scoring criteria. |
| Secondary | Change in Vitiligo Area and Severity Index (VASl) Score | From enrollment to the end of treatment at 6 months. | Calculate the difference between the VASl score at 6 months and the baseline VASl score, including the mean percentage change in VASI from baseline at 6 months. This reflects the improvement vitiligo area and severity over the treatment period. |
| Secondary | Change in Vitiligo Signs of Activity Score (VSAS) Score | From enrollment to the end of treatment at 6 months. | Calculate the difference between the VSAS score at 6 months and the baseline VSAS score. |
| Secondary | Change in Vitiligo Extent Score (VES) Score | From enrollment to the end of treatment at 6 months. | Calculate the difference between the VES score at 6 months and the baseline VES score. |
| Secondary | Change in Vitiligo European Task Force (VETF) Score | From enrollment to the end of treatment at 6 months. | Calculate the difference between the VETF score at 6 months and the baseline VETF score. |
| Secondary | Change in Dermatology life quality index (DLQI) Score | From enrollment to the end of treatment at 6 months. | Description \& Structure: Dermatology Life Quality Index (DLQI) is a 10-item, disease-specific quality of life questionnaire designed for adults with skin conditions. It assesses the impact of skin disease across three domains: Physical, Social, and Psychological impacts. Children Dermatology life quality index (CDLQI) is the children's version of the DLQI, which is suitable for children aged 5 to 16 years. For young children, parental assistance or proxy completion is recommended. Scoring Range: Each item is rated on a 4-point Likert scale (0 = "Not at all", 1 = "A little", 2 = "Quite a lot", 3 = "Very much"). The total score is the sum of all 10 items, ranging from 0 to 30. Score Direction \& Interpretation: A higher total score indicates a greater negative impact on the child's disease-specific quality of life (a worse outcome). A decrease in the score from baseline represents an improvement in quality of life. |
| Secondary | Change in The Vitiligo-specific Quality-of-Life instrument (VitiQoL) Score | From enrollment to the end of treatment at 6 months. | Description \& Structure: The VitiQoL is a 15-item, disease-specific quality of life questionnaire designed for patients with vitiligo. It comprises three subdomains: Psychological Burden, Activity Limitation, and Appearance Concerns. Patients are asked to recall their experience over the past week and rate how bothered they have been by each item on a 5-point Likert scale (0 = "Never", 1 = "Rarely", 2 = "Sometimes", 3 = "Often", 4 = "Always"). Scoring Range: The total score ranges from 0 to 60, calculated by summing the scores of all 15 items. Score Direction \& Interpretation: A higher total score indicates greater impairment in disease-specific quality of life (worse outcome). A decrease in score from baseline represents an improvement. |
| Secondary | Proportion of Participants Achieving investigator Global Assessment (lGA) Score lmprovement | From enrollment to the end of treatment at 6 months. | Assess participants' lGA scores at 24 weeks. Participants with an lGA score of "mild" or better (score s 2) are defined as achieving improvement, and the proportion is calculated. |
| Secondary | Incidence of Treatment-Emergent Adverse Events | From enrollment to the end of treatment at 6 months. | All surgery-related and disease-related adverse events, such as localized erythema, pruritus, scarring, and Koebner phenomenon, will be documented and analyzed, including their incidence, severity, and association with the interventions. |
| Other | Changes in levels of 12 serum cytokines | From enrollment to the end of treatment at 6 months. | Venous blood will be collected from the elbow at baseline and at 1, 3, and 6 months post-treatment to measure 12 serum cytokines (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-17, IFN-α, IFN-γ, TNF-α). The changes in levels will be statistically analyzed to explore their correlation with clinical response and the underlying mechanisms of treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07307534/registered