Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study.
Administration, Cutaneous
Adult
Calcineurin Inhibitors
/ administration & dosage
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
Treatment Outcome
Vitiligo
/ drug therapy
Journal
The Journal of investigative dermatology
ISSN: 1523-1747
Titre abrégé: J Invest Dermatol
Pays: United States
ID NLM: 0426720
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
11
11
2020
revised:
15
12
2020
accepted:
20
12
2020
pubmed:
8
2
2021
medline:
24
11
2021
entrez:
7
2
2021
Statut:
ppublish
Résumé
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. 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. This study was a 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension. Participants included were adult patients with recent facial vitiligo target lesions (<2 years) without changes in pigmentation or size over the previous 3 months. Patients received either tacrolimus 0.1% ointment or vehicle twice daily. 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. 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. 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. This study was registered at ClinicalTrials.gov (identifier: NCT02466997).
Sections du résumé
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
Patients received either tacrolimus 0.1% ointment or vehicle twice daily.
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).
Identifiants
pubmed: 33549606
pii: S0022-202X(21)00077-4
doi: 10.1016/j.jid.2020.12.028
pii:
doi:
Substances chimiques
Calcineurin Inhibitors
0
Ointments
0
Tacrolimus
WM0HAQ4WNM
Banques de données
ClinicalTrials.gov
['NCT02466997']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1728-1734Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.