Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
Overview
- Phase
- Not Applicable
- Intervention
- Triamcinolone acetonide 0.4mg/cc
- Conditions
- Vitiligo
- Sponsor
- The Catholic University of Korea
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- The repigmentation rate (change from baseline) of the vitiliginous patch
- Last Updated
- 8 years ago
Overview
Brief Summary
A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo
Detailed Description
Intralesional corticosteroid injections have been a long-standing treatment for refractory vitiligo, with some patients showing significant improvement without surgical intervention. The investigators will perform a randomized split-body pilot trial to test the exact efficacy of intralesional triamcinolone injections. The paired symmetric vitiliginous lesions will be randomized to either control or injection groups. All lesions will be treated with narrowband UV-B phototerapy or excimer laser weekly and twice daily application of topical tacrolimus ointment for a total of 12-week period. Intralesional injections of 0.4mg/cc triamcinolone once a week are given to the experimental group. The degree of repigmentation will be assessed as % from baseline.
Investigators
Jung Min Bae
Assistant Professor
The Catholic University of Korea
Eligibility Criteria
Inclusion Criteria
- •Age : 19 or older
- •A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study
- •A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk
- •A patient who has no further response to excimer laser or short wavelength ultraviolet B therapy, which is a conventional treatment for vitiligo
Exclusion Criteria
- •Patients under the age of 19
- •Patients with enlarged or spreading lesions of vitiligo
- •Patients who do not want to do so or who refuse to write a consent form
- •Patients who are inadequate for triamcinolone acetonide administration (pregnant women, infectious and systemic fungal infections without effective antimicrobial agents, immunosuppression, hypersensitivity reactions to and concomitant use of triamcinolone or its components, spontaneous thrombocytopenia, purpura, herpes simplex, shingles, chicken pox patients)
- •Others those who are deemed unsuitable for the examination at the discretion of the examiner
Arms & Interventions
Experimental group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period. Intervention: Intralesional injection of triamcinolone acetonide (0.4mg/cc) will be performed weekly.
Intervention: Triamcinolone acetonide 0.4mg/cc
Experimental group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period. Intervention: Intralesional injection of triamcinolone acetonide (0.4mg/cc) will be performed weekly.
Intervention: Phototherapy (NBUVB or excimer laser)
Experimental group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period. Intervention: Intralesional injection of triamcinolone acetonide (0.4mg/cc) will be performed weekly.
Intervention: Topical tacrolimus
Control group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
Intervention: Phototherapy (NBUVB or excimer laser)
Control group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
Intervention: Topical tacrolimus
Outcomes
Primary Outcomes
The repigmentation rate (change from baseline) of the vitiliginous patch
Time Frame: Baseline and 12 weeks
The degree of repigmentation will be assessed as % from baseline by using a computer program.
Secondary Outcomes
- The adverse effects(every weeks up to 13 weeks)