A multicentre, randomized, double-masked, parallel group, vehicle-controlled phase IIb study to evaluate the safety and efficacy of 1% and 3% topical minocycline gel in patients with papulopustular rosacea

Source: British Journal of Dermatology, Accepted for publication 5 January 2020

G. Webster,¹ Z.D. Draelos,² E. Graber,³ M.S. Lee,⁴ S. Dhawan,⁵M. Salman⁶ and G.N. Magrath^6,7

¹Department of Dermatology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA
²Dermatology Consulting Services, High Point, NC, USA
³Northeastern University and The Dermatology Institute of Boston, Boston, MA, USA
⁴Lee Medical Associates, San Antonio, TX, USA
⁵Center for Dermatology, Cosmetic, and Laser Surgery, Freemont, CA, USA
⁶Hovione Scientia Ltd., Loughbeg, Ringaskiddy, Cork, Ireland
⁷Medical University of South Carolina, Charleston, SC, USA

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.
Objectives To assess the safety and efficacy of once-daily topical minocycline gel 1% and 3% in patients with papulopustular rosacea.
Methods This was a prospective, 12-week, double-blinded study conducted at 26 sites in the United States; 270 patients with papulopustular rosacea and 12–40 inflammatory lesions were randomized to minocycline 1%, minocycline 3% or vehicle. The primary endpoint was the mean change in inflammatory lesions at week 12. Key secondary endpoints included success on an Investigator’s Global Assessment (IGA).

Results
Baseline mean lesion counts were 246, 251 and 243 in the minocycline 1%, minocycline 3% and vehicle groups, respectively; at week 12, the counts had decreased by 126, 131 and 79, respectively. Minocycline significantly decreased lesions, compared with the vehicle [P = 001, 95% confidence interval (CI) 79 to 09, for minocycline 1%; P = 0007, 95% CI 83 to 13, for minocycline 3%]. The proportion of patients achieving IGA success was 39% in the minocycline 1% arm [P = 034, odds ratio (OR) 1396 and OR 95% CI 071 to 275 vs. vehicle], 46% in the minocycline 3% arm (P = 004, OR 203 and OR 95% CI 104 to 395 vs. vehicle) and 31% in the vehicle arm.
 

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