Efficacy and Safety of Intralesional Corticosterois in the Treatment of Vitiligo
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitiligo
Intervention: Triamcinolone Acetonide (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Harvey Lui, MD, FRCPC, Principal Investigator, Affiliation: University of British Columbia
Overall contact: Harvey Lui, MD, FRCPC, Phone: 16048754111, Ext: 68691, Email: harvey.lui@ubc.ca
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).
Clinical Details
Official title: Efficacy and Safety of Intralesional Triamcinolone Acetonide in Vitiligo: A Prospective, Double-Blind Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.
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
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Harvey Lui, MD, FRCPC, Phone: 16048754111, Ext: 68691, Email: harvey.lui@ubc.ca
The Skin Care Center, Vancouver General Hospital, Vancouver, British Columbia V5Z 4E8, Canada; Recruiting Harvey Lui, MD FRCPC, Phone: 16048754111, Ext: 68691, Email: harvey.lui@ubc.ca Harvey Lui, MD FRCPC, Principal Investigator
Additional Information
Starting date: January 2013
Last updated: June 30, 2015
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