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

NCT02191748 | Terminated Phase 2

• 1 other identifier: Pro2013003377
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (16)

• 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

Study Arms (3)

Needling

ACTIVE COMPARATOR

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 and Triamcinolone

EXPERIMENTAL

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; Drug: Triamcinolone

No treatment

NO INTERVENTION

No treatment will be done to these vitiligo patches as a control.

Interventions

Needling PROCEDURE

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.

Needling; Needling and Triamcinolone

Triamcinolone DRUG

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

Also known as: Kenalog

Needling and Triamcinolone

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Unstable vitiligo
• \. Allergic to triamcinolone
• \. Systemic treatments
• \. Pregnancy

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

RWJUH Dermatology office

Somerset, New Jersey, 08873, United States

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Triamcinolone; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Babar Rao, MD

  RWJUH Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: July 16, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

US (1)