Clinical trial NCT02191748: Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo
Official title: Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Vitiligo
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Repigmentation of vitiligo patch using confocal microscopy
timeFrame: baseline
measure: Repigmentation of vitiligo patch using confocal microscopy
timeFrame: week 4 post treatment (only if repigmentation become first apparent at this time point)
measure: Repigmentation of vitiligo patch using confocal microscopy
timeFrame: week 8 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
timeFrame: week 12 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
timeFrame: week 16 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
timeFrame: week 20 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
timeFrame: week 24 post treatment (only if repigmentation become first apparent at this time point
measure: Repigmentation of vitiligo patch using confocal microscopy
timeFrame: week 28 post treatment
Secondary outcomes:
measure: Photography measure to assess repigmentation
timeFrame: baseline
measure: Wood's lamp to assess repigmentation
timeFrame: baseline
measure: Photography measure to assess repigmentation
timeFrame: week 4 post treatment
measure: Photography measure to assess repigmentation
timeFrame: week 8 post treatment
measure: Photography measure to assess repigmentation
timeFrame: week 12 post treatment
measure: Photography measure to assess repigmentation
timeFrame: week 16 post treatment
measure: Photography measure to assess repigmentation
timeFrame: week 20 post treatment
measure: Photography measure to assess repigmentation
timeFrame: week 24 post treatment
measure: Photography measure to assess repigmentation
timeFrame: week 28 post treatment
measure: Wood's lamp to assess repigmentation
timeFrame: week 4 post treatment
measure: Wood's lamp to assess repigmentation
timeFrame: week 8 post treatment
measure: Wood's lamp to assess repigmentation
timeFrame: week 12 post treatment
measure: Wood's lamp to assess repigmentation
timeFrame: week 16 post treatment
measure: Wood's lamp to assess repigmentation
timeFrame: week 20 post treatment
measure: Wood's lamp to assess repigmentation
timeFrame: week 24 post treatment
measure: Wood's lamp to assess repigmentation
timeFrame: week 28 post treatment
Other outcomes:
Locations:
city: Somerset
country: United States
facility: RWJUH Dermatology office
state: New Jersey
Study officials:
affiliation: RWJUH Dermatology
name: Babar Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: