Minocycline 1.5% foam for the topical treatment of moderate to severe papulopustular rosacea: Results of 2 phase 3, randomized, clinical trials.
Administration, Topical
Adult
Dermatologic Agents
/ administration & dosage
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Humans
Male
Middle Aged
Minocycline
/ administration & dosage
Prognosis
Rosacea
/ diagnosis
Severity of Illness Index
Treatment Outcome
United States
Young Adult
double-blind clinical trial
facial
minocycline
papulopustular rosacea
phase 3
topical foam
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
May 2020
May 2020
Historique:
received:
06
11
2019
revised:
21
01
2020
accepted:
22
01
2020
pubmed:
1
2
2020
medline:
25
11
2020
entrez:
1
2
2020
Statut:
ppublish
Résumé
Efficacious topical medications for rosacea are needed. FMX103 1.5% is a novel topical minocycline foam that may have therapeutic benefits in treating rosacea while minimizing systemic adverse effects due to its topical route of delivery. To determine the efficacy, safety, and tolerability of 12 weeks of treatment with FMX103 1.5% topical minocycline foam for papulopustular rosacea. Two 12-week, phase 3, randomized, multicenter, double-blind, vehicle-controlled, 2-arm studies were performed in patients with moderate to severe papulopustular rosacea. Participants who received FMX103 1.5%, versus control individuals treated with vehicle, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P = .0031; FX2016-12: -18.54 vs -14.88; P < .0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P = .0273; FX2016-12: 49.1% vs 39.0%; P = .0077). No serious treatment-related treatment-emergent adverse events occurred. The generalizability of these data from a controlled clinical trial should be examined in a real-world setting. FMX103 1.5% was efficacious for moderate to severe papulopustular rosacea and maintained a favorable safety profile.
Sections du résumé
BACKGROUND
BACKGROUND
Efficacious topical medications for rosacea are needed. FMX103 1.5% is a novel topical minocycline foam that may have therapeutic benefits in treating rosacea while minimizing systemic adverse effects due to its topical route of delivery.
OBJECTIVE
OBJECTIVE
To determine the efficacy, safety, and tolerability of 12 weeks of treatment with FMX103 1.5% topical minocycline foam for papulopustular rosacea.
METHODS
METHODS
Two 12-week, phase 3, randomized, multicenter, double-blind, vehicle-controlled, 2-arm studies were performed in patients with moderate to severe papulopustular rosacea.
RESULTS
RESULTS
Participants who received FMX103 1.5%, versus control individuals treated with vehicle, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P = .0031; FX2016-12: -18.54 vs -14.88; P < .0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P = .0273; FX2016-12: 49.1% vs 39.0%; P = .0077). No serious treatment-related treatment-emergent adverse events occurred.
LIMITATIONS
CONCLUSIONS
The generalizability of these data from a controlled clinical trial should be examined in a real-world setting.
CONCLUSIONS
CONCLUSIONS
FMX103 1.5% was efficacious for moderate to severe papulopustular rosacea and maintained a favorable safety profile.
Identifiants
pubmed: 32004648
pii: S0190-9622(20)30127-4
doi: 10.1016/j.jaad.2020.01.043
pii:
doi:
Substances chimiques
Dermatologic Agents
0
Minocycline
FYY3R43WGO
Types de publication
Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1166-1173Informations de copyright
Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.