Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo

Stopped early · Phase 2/Phase 3

Conditions studied: Vitiligo

In brief

Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented areas of skin. In the United States, vitiligo affects 1% of patients, causing not only changes in the color of skin, but also significant cosmetic concerns and quality of life issues. Current treatment modalities, which include topical corticosteroids, intralesional corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment. There is a need for new, effective modalities to treat patients with otherwise refractory vitiligo. Needling is an office based procedure that theoretically transposes healthy, pigmented skin cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of needling as a novel treatment for vitiligo had promising results but were limited by small sample size and subjective results. The proposed randomized control trial (RCT) will further investigate the use of needling to treat vitiligo. It differs from the previous studies in that it seeks to identify the cause of clinical benefit by comparing needling alone to needling with corticosteroid, examines a larger number of patients, and quantifies improvement using confocal microscopy. Confocal microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has been used in the past to diagnose cutaneous pigmentary conditions. This study would be the first RCT of needling in vitiligo to use an objective measure to quantify results, thus has the potential to establish needling as a novel, effective treatment for vitiligo and to evaluate the utility of CFM for monitoring response to treatment.

Key facts

Study ID

NCT02191748

Run by

Rutgers, The State University of New Jersey

People needed

22

Starts

2014-09-01

Expected to finish

2018-01-01

Last updated by the study team

2017-07-25

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Patients with 3 or more localized patches of stable vitiligo
• 2. No prior treatment or had failed previous vitiligo treatments

You may not qualify if…

• 1. Unstable vitiligo
• 2. Allergic to triamcinolone
• 3. Systemic treatments
• 4. Pregnancy

Where it is running

• RWJUH Dermatology office — Somerset, New Jersey, United States

Full record on ClinicalTrials.gov

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