Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

The Catholic University of Korea

Status: Unknown

Conditions: Corticosteroid; Treatment; Vitiligo; Intralesional Injection

Treatments: Drug: Topical tacrolimus; Device: Phototherapy (NBUVB or excimer laser); Drug: Triamcinolone acetonide 0.4mg/cc

Study type: Interventional

Funder types: Other

Identifiers

NCT03365141

VC17MESI0190

Details and patient eligibility

About

A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Drug: Topical tacrolimus

Drug: Triamcinolone acetonide 0.4mg/cc

Device: Phototherapy (NBUVB or excimer laser)

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Topical tacrolimus

Device: Phototherapy (NBUVB or excimer laser)