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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
Author(s) -
Webster G.,
Draelos Z.D.,
Graber E.,
Lee M.S.,
Dhawan S.,
Salman M.,
Magrath G.N.
Publication year - 2020
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.18857
Subject(s) - minocycline , rosacea , papulopustular , medicine , erythema , dermatology , clinical endpoint , randomized controlled trial , gastroenterology , surgery , acne , antibiotics , microbiology and biotechnology , biology
Summary 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 24·6, 25·1 and 24·3 in the minocycline 1%, minocycline 3% and vehicle groups, respectively; at week 12, the counts had decreased by 12·6, 13·1 and 7·9, respectively. Minocycline significantly decreased lesions, compared with the vehicle [ P = 0·01, 95% confidence interval ( CI ) 7·9 to 0·9, for minocycline 1%; P = 0·007, 95% CI 8·3 to 1·3, for minocycline 3%]. The proportion of patients achieving IGA success was 39% in the minocycline 1% arm [ P = 0·34, odds ratio ( OR ) 1·396 and OR 95% CI 0·71 to 2·75 vs. vehicle], 46% in the minocycline 3% arm ( P = 0·04, OR 2·03 and OR 95% CI 1·04 to 3·95 vs. vehicle) and 31% in the vehicle arm. Conclusions Minocycline topical gel appears to be safe and tolerable at concentrations of 1% and 3%, and both concentrations significantly decreased inflammatory lesion counts, with a significantly larger proportion of patients achieving IGA success at week 12 in the minocycline 3% arm. These findings support further evaluation of minocycline gel for treating inflammatory lesions associated with papulopustular rosacea. Linked Comment: Hampton. Br J Dermatol 2020; 183 :412–413.