Analyzing the molecular pathways in vitiligo lesions that respond or do not respond to treatment
Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions
This study is trying to see how well a combination of pills and light therapy works for treating vitiligo by looking at skin samples from people with the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05927272 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the molecular pathways involved in vitiligo lesions that either respond or do not respond to treatment. Participants will undergo a combination treatment of oral mini-pulse methylprednisolone and narrowband UVB phototherapy. Skin biopsies will be collected at baseline, 3 months, and 6 months, along with blood samples taken at specified intervals to measure inflammatory markers. The study will correlate these findings with clinical data to better understand the disease's progression and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with active non-segmental vitiligo affecting more than 5% of their body surface area.
Not a fit: Patients with segmental or mixed vitiligo, or those unable to comply with study procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with vitiligo by identifying effective pathways for repigmentation.
How similar studies have performed: While there have been studies on vitiligo treatments, this specific approach focusing on transcriptomic signatures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject: male or female aged ≥ 18 years and ≤ 65 years * Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved \>5% excluding hands and feet, with lesions located on arms * Active non-segmental vitiligo is defined by: * Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND * Presence of hypochromic aspect under Wood's lamp examination and/or perifollicular hypopigmentation under Wood's lamp examination. * Able to read, understand, and give documented informed consent * Registered in the French Social Security * Patients that could receive the combination of oral steroids and phototherapy according the recommendation * Signed informed consent form Exclusion Criteria: * Segmental or mixed vitiligo * Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures. * Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Where this trial is running
Bordeaux
- University Hospital of Bordeaux - St André Hospital — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Julien SENESCHAL, MD, PhD — University Hospital, Bordeaux
- Study coordinator: Julien SENESCHAL, MD, PhD
- Email: julien.seneschal@chu-bordeaux.fr
- Phone: +33 (0)5 56 79 49 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.