NCT03270241

Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients' quality of life across all degrees of involvement and severity. Phototherapy, such as Narrow band UVB (NB-UVB), is a clinically indicated treatment for skin lesions. NB-UVB treatment has been shown to promote repigmentation and normalize cellular behaviors. The investigators would like to analyze the change in protein expression and histological change in skin from NB-UVB treatment in participants with Vitiligo. The investigators are recruiting participants with Vitiligo on the body, arms, and/or legs.

Detailed description

This is a dermatology study of the effects of short-term NB-UVB treatment, standard phototherapy for Vitiligo patients. In the study, demographics information, three ascending dose of phototherapy, and small skin biopsies will be required of the participants. For all enrolled participants, the starting dose of NB-UVB administered will be 250 mJ/cm2, which is the standard of care for patients with Vitiligo. The dose will be increased by 10% with each treatment, as long as there are no side effects with treatment such as burning or redness/ erythema. Small skin biopsies will be collected from normal skin and from affected skin from vitiligo participants at the baseline visit and 3 days after the conclusion of treatment; up to a total of 6 biopsies will be collected from each patient. Participants will be compensated for time and effort.

Conditions

• Vitiligo
• Dermatology/Skin - Other

Interventions

Type	Name	Description
DEVICE	Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet	This is an investigator-initiated, single-blinded, ascending dose study of NB-UVB treatment for Vitiligo in adults of 3 treatments for one week. It is designed to measure the molecular changes and re-pigmentation in affected and normal skin of participants with Vitiligo and normal skin in healthy participants.

Timeline

• Start date: 2017-10-01
• Primary completion: 2023-03-14
• Completion: 2023-03-14
• First posted: 2017-09-01
• Last updated: 2024-01-09
• Results posted: 2024-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study