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

Phase 2

Terminated

• Conditions: Vitiligo
• Interventions: Procedure: Needling; Drug: Triamcinolone

• Registration Number: NCT02191748
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Study Start: 2014-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-07-25
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Needling and Triamcinolone	Needling	During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area. Triamcinolone (concentration: 2.5 mg/cc) will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of triamcinolone injected at each site.
Needling	Needling	Needling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch. Saline, which doesn't affect repigmentation in vitiligo, will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of saline injected at each site.
Needling and Triamcinolone	Triamcinolone	During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area. Triamcinolone (concentration: 2.5 mg/cc) will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of triamcinolone injected at each site.

Primary Outcome Measures

Name	Time	Method
Repigmentation of vitiligo patch using confocal microscopy	week 28 post treatment

Secondary Outcome Measures

Name	Time	Method
Photography measure to assess repigmentation	week 28 post treatment
Wood's lamp to assess repigmentation	week 28 post treatment

Trial Locations

Locations (1)

RWJUH Dermatology office; 🇺🇸 Somerset, New Jersey, United States