Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

Not Applicable

• Conditions: Vitiligo; Intralesional Injection; Treatment; Corticosteroid
• Interventions: Drug: Triamcinolone acetonide 0.4mg/cc; Device: Phototherapy (NBUVB or excimer laser); Drug: Topical tacrolimus

• Registration Number: NCT03365141
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2017-11-30
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-05
• Last Update Submitted: 2017-12-05
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Primary Completion: 2018-09-15
• Study Completion: 2018-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Age : 19 or older
2. A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study
3. A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk
4. 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

1. Patients under the age of 19
2. Patients with enlarged or spreading lesions of vitiligo
3. Patients who do not want to do so or who refuse to write a consent form
4. 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)
5. Others those who are deemed unsuitable for the examination at the discretion of the examiner

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Triamcinolone acetonide 0.4mg/cc	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.
Experimental group	Phototherapy (NBUVB or excimer laser)	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.
Control group	Topical tacrolimus	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.
Experimental group	Topical tacrolimus	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.
Control group	Phototherapy (NBUVB or excimer laser)	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.

Primary Outcome Measures

Name	Time	Method
The repigmentation rate (change from baseline) of the vitiliginous patch	Baseline and 12 weeks	The degree of repigmentation will be assessed as % from baseline by using a computer program.

Secondary Outcome Measures

Name	Time	Method
The adverse effects	every weeks up to 13 weeks

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Gyonggi-do, Korea, Republic of