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

Abstract

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.

Rosacea Treatment: Review and Update

“…The efficacy and safety of minocycline foam for the treatment of moderate to severe papulopustular rosacea were evaluated and confirmed in two phase 3, randomized clinical trials (751 and 771 participants, respectively) [ 18 ]. A prospective, 12-week, double-blinded study including 270 patients showed that 3% topical minocycline gel benefitted patients with papulopustular rosacea, significantly decreasing inflammatory lesions compared to vehicle [ 31 ]. A higher proportion of patients using minocycline gel achieved success according to an Investigator's Global Assessment.…”

Expanding treatment options for rosacea

“…In the USA, where state-level registry reporting of incident cases is not mandatory, NMSC results in annual healthcare costs of~$426 million among Medicare patients, making it the fifth costliest after prostate, lung, colon and breast carcinomas. 2 Prevention remains a key factor in reducing incidence, with avoidance or reduction of solar radiation exposure being paramount. Nevertheless, identification of ubiquitous risk factors and/or effect modifiers of ultraviolet exposure is crucial for reducing this burden.…”

“…In this issue of the BJD, Webster et al report the beneficial effects of topical minocycline on papulopustular rosacea. 2 The precise mechanism of action of tetracyclines in rosacea remains unclear. Multiple anti-inflammatory effects have been reported including inhibition of proinflammatory cytokines and matrix metalloproteinases, scavenging of reactive oxygen species, inhibition of neutrophil migration and adherence and reduced proliferation of lymphocytes.…”

“…In this issue of the BJD , Webster et al . report the beneficial effects of topical minocycline on papulopustular rosacea . The precise mechanism of action of tetracyclines in rosacea remains unclear.…”

“…Therefore, the investigation of topical minocycline published in this issue of the BJD by Webster et al . is welcome . Oral minocycline is no longer widely prescribed due to the significant adverse side‐effect profile associated with systemic use.…”