Jump to content
  • Sign Up
Sign in to follow this  
rss

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.

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

Share this post


Link to post
Share on other sites

Join the conversation

You can post now and register later. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Sign in to follow this  

×
×
  • Create New...