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

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.

Study Overview

• Status: Terminated
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: Needling; Drug: Triamcinolone

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • RWJUH Dermatology office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: Needling and 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.	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; Other Names: Kenalog
No Intervention: No treatment; No treatment will be done to these vitiligo patches as a control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Repigmentation of vitiligo patch using confocal microscopy	baseline
Repigmentation of vitiligo patch using confocal microscopy	week 4 post treatment (only if repigmentation become first apparent at this time point)
Repigmentation of vitiligo patch using confocal microscopy	week 8 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy	week 12 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy	week 16 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy	week 20 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy	week 24 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy	week 28 post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Photography measure to assess repigmentation	baseline
Wood's lamp to assess repigmentation	baseline
Photography measure to assess repigmentation	week 4 post treatment
Photography measure to assess repigmentation	week 8 post treatment
Photography measure to assess repigmentation	week 12 post treatment
Photography measure to assess repigmentation	week 16 post treatment
Photography measure to assess repigmentation	week 20 post treatment
Photography measure to assess repigmentation	week 24 post treatment
Photography measure to assess repigmentation	week 28 post treatment
Wood's lamp to assess repigmentation	week 4 post treatment
Wood's lamp to assess repigmentation	week 8 post treatment
Wood's lamp to assess repigmentation	week 12 post treatment
Wood's lamp to assess repigmentation	week 16 post treatment
Wood's lamp to assess repigmentation	week 20 post treatment
Wood's lamp to assess repigmentation	week 24 post treatment
Wood's lamp to assess repigmentation	week 28 post treatment

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Babar Rao, MD, RWJUH Dermatology

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: Pro2013003377