Back to Search
Start Over
Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study
- Source :
- Journal of Investigative Dermatology, Journal of Investigative Dermatology, Nature Publishing Group, 2021, 141 (7), pp.1728-1734. ⟨10.1016/j.jid.2020.12.028⟩
- Publication Year :
- 2021
- Publisher :
- HAL CCSD, 2021.
-
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 ( 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 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 ).
- Subjects :
- Adult
Male
0301 basic medicine
Target lesion
medicine.medical_specialty
Double blinded
Calcineurin Inhibitors
Population
Vitiligo
Skin Pigmentation
Dermatology
Administration, Cutaneous
Off-label use
Biochemistry
Drug Administration Schedule
Tacrolimus
Ointments
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Internal medicine
medicine
Humans
education
Molecular Biology
ComputingMilieux_MISCELLANEOUS
education.field_of_study
Adult patients
business.industry
Cell Biology
Middle Aged
medicine.disease
Calcineurin
Treatment Outcome
030104 developmental biology
Patient Satisfaction
030220 oncology & carcinogenesis
Female
business
Facial Dermatoses
[SDV.MHEP.DERM]Life Sciences [q-bio]/Human health and pathology/Dermatology
Follow-Up Studies
Subjects
Details
- Language :
- English
- ISSN :
- 0022202X and 15231747
- Database :
- OpenAIRE
- Journal :
- Journal of Investigative Dermatology, Journal of Investigative Dermatology, Nature Publishing Group, 2021, 141 (7), pp.1728-1734. ⟨10.1016/j.jid.2020.12.028⟩
- Accession number :
- edsair.doi.dedup.....1b0d86654fbcfae5c70268b89a015657
- Full Text :
- https://doi.org/10.1016/j.jid.2020.12.028⟩