Recruiting
Phase 2

Corticosteroids

Sponsor:

University of British Columbia

Code:

NCT01766609

Conditions

Vitiligo

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Triamcinolone Acetonide

Study Details

Brief summary:

Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin. It has a major psychosocial impact on affected patients. There are many treatment modalities available for vitiligo, however, none of them cure the disease. Topical corticosteroids (CS) are the most effective monotherapy for localized vitiligo. Treatment with intralesional corticosteroids (ILCS) is commonly used in many dermatologic conditions. However, there are only a few studies published on the use of ILCS in vitiligo. This is a prospective double-blind randomized clinical trial to assess efficacy and safety of ILCS in the treatment of vitiligo. Four treatment sessions will be done over 4 to 6 months. The investigators will compare intralesional triamcinolone acetonide (active treatment) to normal saline (placebo).

Conditions

Vitiligo

Study ID

NCT01766609

Start date

Jan, 2013

Status verified date

Jun, 2015

Completion date

Jan, 2016

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 18 years.
  • Localized or generalized vitiligo that involves a non mucosal or acral site.
  • Patients should have a patch of at least 5 cm in the smallest diameter that shows no more than 10% repigmentation as assessed visually

Exclusion Criteria:

  • Patients who received treatment for vitiligo within the past 4 weeks.
  • Hypersensitivity to TA or vehicle.
  • Pregnancy or breast-feeding.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: A: Triamcinolone acetonide

Injections will be given within one half of a single vitiligo patch. The concentration of triamcinolone acetonide (TA) that will be used initially is 2.5 mg/ml. Dilution will be done using a bacteriostatic normal saline. Each half will receive injections with either TA 2.5 mg/ml or normal saline as a control. Only one investigator will know the intervention each half has received. If the patient did not show any evidence of repigmentation during the 3rd visit (i.e. after two injection sessions with TA 2.5 mg/ml) , the concentration of TA will be increased to 5 mg/ml. A total of 4 injections will be given over 4 visits. The treatment will be repeated every 3 to 5 weeks for a total of 4 treatment sessions.

placebo comparator: B: Normal saline

Bacteriostatic normal saline will injected into one half of the vitiligo patch.

Interventions

Triamcinolone Acetonide

Primary outcome measure

  • Assessment of the degree of repigmentation based on the modified VASI score for each half. We will consider the treatment successful if there was ≥50% change in modified VASI score from baseline. [ Time Frame: 3-5 weeks after each treatment session ]

Central Contacts and Locations

Central contacts

Harvey Lui, MD, FRCPC

16048754111harvey.lui@ubc.ca

Locations

The Skin Care Center, Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E8

Contacts

Harvey Lui, MD FRCPC

16048754111harvey.lui@ubc.ca

Principal Investigator:

Harvey Lui, MD FRCPC

More Information

Sponsor

University of British Columbia

Last update posted

Jul 2, 2015

Last verified

Jun, 2015

Keywords

  • Vitiligo; Intralesional; Triamcinolone acetonide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of British Columbia on 2015-07-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.