Efficacy and Safety of Intralesional Corticosterois in the Treatment of Vitiligo

NCT01766609 | Unknown Phase 2

• 1 other identifier: H12-02140
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Vitiligo; Intralesional; Triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

• 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.

  3-5 weeks after each treatment session

Secondary Outcomes (1)

• Assessment of side effects in each half including atrophy, telangiectasia, hyperpigmentation and hypopigmentation using a severity scale as follows: 0=none, 1=mild, 2=moderate, 3=severe.

  3-5 weeks after each treatment session

Study Arms (2)

A: Triamcinolone acetonide

ACTIVE COMPARATOR

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.

Drug: Triamcinolone Acetonide

B: Normal saline

PLACEBO COMPARATOR

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

Interventions

Triamcinolone Acetonide DRUG

A: Triamcinolone acetonide

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

The Skin Care Center, Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E8, Canada

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Harvey Lui, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harvey Lui, MD, FRCPC

CONTACT

16048754111; harvey.lui@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 11, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: July 2, 2015

Record last verified: 2015-06

Locations

CA (1)