Efficacy and Safety of Intralesional Corticosterois in the Treatment of Vitiligo

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01766609
First received: January 9, 2013
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention Phase
Vitiligo
Drug: Triamcinolone Acetonide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intralesional Triamcinolone Acetonide in Vitiligo: A Prospective, Double-Blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3-5 weeks after each treatment session ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Triamcinolone Acetonide
Placebo Comparator: B: Normal saline
Bacteriostatic normal saline will injected into one half of the vitiligo patch.

Detailed Description:

Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin and mucous membranes. Mucocutaneous lesions develop secondary to selective destruction of melanocytes. It has a major psychosocial impact on affected patients. The etiology of vitiligo is largely unknown but more likely to be multifactorial. There are several theories on the pathogenesis of vitiligo including mainly the autoimmune, neurohormonal, and autocytotoxic theories. The autoimmune hypothesis has the strongest evidence with alteration mainly in the cellular immune response.

Diagnosis of vitiligo is usually made clinically. A skin biopsy is rarely needed for diagnosis and typically shows absence of melanin in the epidermis with no or few melanocytes. Perivascular inflammation has been found in approximately 92% of cases. Spontaneous repigmentation is uncommon (seen in 10-20% of patients) in vitiliginous patches but can occur. Repigmentation occurs usually in a perifollicular pattern, suggesting that the hair follicle functions as a reservoir for melanocytes.

There are many treatment modalities available for vitiligo, however, none of them cure the disease. These include different topical treatments, phototherapy, surgical therapy, and depigmentation therapy. Topical corticosteroids (CS) are commonly used as a first-line therapy for localized vitiligo. They are the most effective monotherapy for localized vitiligo. Studies have shown an increase in inflammatory cells in vitiliginous skin, mainly macrophages and T cells. Efficacy of CS in vitiligo is attributed to modulation of the immune response, reduction of destruction of melanocytes, and induction of melanocyte proliferation and melanin production. Treatment with intralesional corticosteroids (ILCS) is commonly used in many dermatologic conditions. There are only a few studies published on the use of ILCS in vitiligo. Triamcinolone acetonide (TA) is the most commonly used form of ILCSs. It is characterized by low solubility, being slowly absorbed from the injection site, prompting maximal local action, limiting diffusion and spread through tissue, and not giving rise to systemic side effects if used in therapeutic doses. The concentration that is most commonly used in dermatology is 2.5 mg/ml.

Side effects of intralesional TA (IL TA) include pain at the injection site, mild bleeding, transient atrophy and telangiectasia, hypopigmentation, and hyperpigmentation. Infection is uncommon but caution over bony prominences is recommended. It has been shown that TA at a total dose of 20 mg does not result in adrenal suppression. Hypersensitivity reactions to TA or the vehicle carboxymethylcellulose are extremely rare.

The investigators' hypothesis is that IL TA will induce significant skin pigmentation to improve vitiligo. This due to the anti-inflammatory effect of IL TA. IL TA has been successfully used in the treatment of many skin conditions with an autoimmune pathogenesis including alopecia areata. The investigators plan on conducting a prospective double-blind randomized clinical trial to assess efficacy and safety of IL TA in the treatment of vitiligo.

Study Objectives

  1. To evaluate the potential for IL TA to induce repigmentation within vitiligo patches.
  2. To assess the side effect profile of IL TA when used in the treatment of vitiligo.
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766609

Contacts
Contact: Mohammed AlJasser, MD, FRCPC 17788595522 mj_derma@hotmail.com

Locations
Canada, British Columbia
The Skin Care Center, Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 4E8
Contact: Mohammed AlJasser, MD FRCPC    17788595522    mj_derma@hotmail.com   
Principal Investigator: Harvey Lui, MD FRCPC         
Sponsors and Collaborators
University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01766609     History of Changes
Other Study ID Numbers: H12-02140
Study First Received: January 9, 2013
Last Updated: January 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Vitiligo; Intralesional; Triamcinolone acetonide

Additional relevant MeSH terms:
Hypopigmentation
Vitiligo
Pigmentation Disorders
Skin Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014