Abstract | BACKGROUND: Topical calcineurin inhibitors are used off label in the treatment of vitiligo, and there is a lack of placebo-controlled, blinded studies to support their use. OBJECTIVE: This study aimed to compare the efficacy of tacrolimus 0.1% ointment with that of the vehicle for repigmentation in adult patients with facial vitiligo. DESIGN: This study was a 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension. POPULATION: Participants included were adult patients with recent facial vitiligo target lesions (<2 years) without changes in pigmentation or size over the previous 3 months. INTERVENTION: MAIN OUTCOMES AND MEASURES: The primary outcome was a therapeutic success, defined as a change ≥75% in the repigmentation of the target lesion between baseline and week 24, measured by ImageJ software. Secondary outcome measures were a variation of the physicians' global assessment scores and patients' satisfaction scores, safety data, and the rate of relapse at week 48. RESULTS: A total of 42 patients were included. Therapeutic success was achieved in 65% of tacrolimus-treated patients versus 0% of vehicle-treated patients at week 24 (P < 0.0001). Only 40% of relapse was observed at 48 weeks. CONCLUSIONS AND RELEVANCE: Twice-daily tacrolimus 0.1% ointment showed superior efficacy to that of the vehicle through the 24 weeks of intervention and 24 weeks of follow-up in adult patients with facial vitiligo. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov (identifier: NCT02466997).
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Authors | Julien Seneschal, Alexandra Duplaine, Hervé Maillard, Thierry Passeron, Nicolas Andreu, Régis Lassalle, Clélia Favary, Catherine Droitcourt, Alain Taïeb, Khaled Ezzedine |
Journal | The Journal of investigative dermatology
(J Invest Dermatol)
Vol. 141
Issue 7
Pg. 1728-1734
(07 2021)
ISSN: 1523-1747 [Electronic] United States |
PMID | 33549606
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Calcineurin Inhibitors
- Ointments
- Tacrolimus
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Topics |
- Administration, Cutaneous
- Adult
- Calcineurin Inhibitors
(administration & dosage, adverse effects)
- Double-Blind Method
- Drug Administration Schedule
- Facial Dermatoses
(drug therapy)
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Ointments
- Patient Satisfaction
- Skin Pigmentation
(drug effects)
- Tacrolimus
(administration & dosage, adverse effects)
- Treatment Outcome
- Vitiligo
(drug therapy)
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