Jump to content

PubMed RSS Feed - -A Multicenter, Randomized, Double-Masked, Parallel Group, Vehicle-Controlled Phase 2b Study to evaluate the safety and efficacy of 1% and 3% topical Minocycline Gel in patients with Papulopustular Rosacea.


rss

Recommended Posts

A Multicenter, Randomized, Double-Masked, Parallel Group, Vehicle-Controlled Phase 2b Study to evaluate the safety and efficacy of 1% and 3% topical Minocycline Gel in patients with Papulopustular Rosacea.

Br J Dermatol. 2020 Jan 06;:

Authors: Webster G, Draelos ZD, Graber E, Lee MS, Dhawan S, Salman M, Magrath GN

Abstract
BACKGROUND: Papulopustular rosacea is characterized by chronic facial erythema and inflammatory facial lesions. Minocycline has anti-inflammatory properties which may be effective in the treatment of rosacea inflammatory lesions.
OBJECTIVE: To assess the safety and efficacy of once-daily Minocycline Gel 1% and 3% in subjects with papulopustular rosacea.
METHODS: This was a prospective, double-blinded study conducted at 26 sites in the United States. Subjects with papulopustular rosacea and between 12 and 40 inflammatory lesions were randomized to either 1% minocycline, 3% minocycline, or vehicle. The study product was applied to the face at bedtime for 12 weeks. The primary endpoints was the mean change in inflammatory lesions at week 12. Key secondary endpoints included success on the investigator global assessments (IGA).
RESULTS: 270 subjects were randomized. The baseline mean lesion count was 24.6, 25.1, and 24.3 in the 1% minocycline, 3% minocycline, and vehicle groups, respectively. At week 12, mean inflammatory lesion count had decreased by 12.64 (1% minocycline), 13.09 (3% minocycline), and 7.92 (vehicle). The minocycline treatment arms significantly decreased inflammatory lesions when compared to vehicle (p=0.01, 95% CI -7.930 to -0.871 for 1% minocycline and p=0.007, 95% CI -8.319 to -1.310 for 3% minocycline). The proportion of subjects achieving IGA success was 38.9% in the 1% minocycline group (p=0.34, OR 1.396 and OR 95% CI 0.708 to 2.751 vs. vehicle), 46.2% in the 3% minocycline group (p=0.04, OR 2.028 and OR 95% CI 1.040 to 3.952 vs. vehicle), and 30.8% in the vehicle group.
CONCLUSION: 1% and 3% topical minocycline gel appears safe and tolerable. 1% and 3% topical minocycline gel significantly decreased inflammatory lesion counts and a significantly larger proportion of subjects achieved IGA success at week 12 in the 3% topical minocycline group. These findings support further evaluation of minocycline gel for the treatment of inflammatory lesions associated with papulopustular rosacea.

PMID: 31907924 [PubMed - as supplied by publisher]

{url} = URL to article

Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
×
×
  • Create New...

Important Information

Terms & Rules