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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02191748
• Other study ID #: Pro2013003377
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 3, 2014
• Last updated: July 21, 2017
• Start date: September 2014
• Est. completion date: January 2018

Study information

• Verified date: July 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Procedure:
• 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.

Drug:
• 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

Locations

Country	Name	City	State
United States	RWJUH Dermatology office	Somerset	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repigmentation of vitiligo patch using confocal microscopy		baseline
Primary	Repigmentation of vitiligo patch using confocal microscopy		week 4 post treatment (only if repigmentation become first apparent at this time point)
Primary	Repigmentation of vitiligo patch using confocal microscopy		week 8 post treatment (only if repigmentation become first apparent at this time point
Primary	Repigmentation of vitiligo patch using confocal microscopy		week 12 post treatment (only if repigmentation become first apparent at this time point
Primary	Repigmentation of vitiligo patch using confocal microscopy		week 16 post treatment (only if repigmentation become first apparent at this time point
Primary	Repigmentation of vitiligo patch using confocal microscopy		week 20 post treatment (only if repigmentation become first apparent at this time point
Primary	Repigmentation of vitiligo patch using confocal microscopy		week 24 post treatment (only if repigmentation become first apparent at this time point
Primary	Repigmentation of vitiligo patch using confocal microscopy		week 28 post treatment
Secondary	Photography measure to assess repigmentation		baseline
Secondary	Wood's lamp to assess repigmentation		baseline
Secondary	Photography measure to assess repigmentation		week 4 post treatment
Secondary	Photography measure to assess repigmentation		week 8 post treatment
Secondary	Photography measure to assess repigmentation		week 12 post treatment
Secondary	Photography measure to assess repigmentation		week 16 post treatment
Secondary	Photography measure to assess repigmentation		week 20 post treatment
Secondary	Photography measure to assess repigmentation		week 24 post treatment
Secondary	Photography measure to assess repigmentation		week 28 post treatment
Secondary	Wood's lamp to assess repigmentation		week 4 post treatment
Secondary	Wood's lamp to assess repigmentation		week 8 post treatment
Secondary	Wood's lamp to assess repigmentation		week 12 post treatment
Secondary	Wood's lamp to assess repigmentation		week 16 post treatment
Secondary	Wood's lamp to assess repigmentation		week 20 post treatment
Secondary	Wood's lamp to assess repigmentation		week 24 post treatment
Secondary	Wood's lamp to assess repigmentation		week 28 post treatment