A Prospective Multi-Arm Blinded Evaluator Within-subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for the Repigmentation of Stable Vitiligo Lesions

Date Added
May 24th, 2021
PRO Number
Pro00107906
Researcher
Steven Kahn

List of Studies


Keywords
Cosmetic Procedures, Skin, Surgery, Transplant
Summary

This is a randomized study to evaluate the clinical performance of RECELL for re-pigmentation of stable, de-pigmented skin in subjects 18 years or older. RECELL is a device that takes a small sample of skin from one location on the participant's body, processes that sample into a spray, and then applies that spray to the depigmented skin on the participant's body. Each participant will have some depigmented skin that is not treated by the RECELL device, so that a comparison can be made to the treated areas. The participant will be asked to return for a follow-up visit 1, 4, 12, 24, 36, and 52 weeks after their treatment, so that the research study team can assess their outcome.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

A Proof of Concept, Split Study, Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo.

Date Added
March 2nd, 2021
PRO Number
Pro00104695
Researcher
Joni Mazza-McCrann

List of Studies


Keywords
Cosmetic Procedures, Drug Studies, Ethnicity and Disease, Skin
Summary

The purpose of this research is to treat vitiligo with topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment.

The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.

Enrolled subjects will present biweekly to clinic for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study.

The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Gabriella Santa Lucia
7244138833
grs200@musc.edu



-- OR --