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A phase III, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of M605108 in patients with acne vulgaris

A phase III, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of M605108 in patients with acne vulgaris

222

The ratio of male and female patients was comparable in the entire study population and there was no significant gender bias between 2.5% M605108 group and M605108 vehicle group (hereinafter, vehicle group). The overall mean age was 20.7 years (20.8 years for 2.5% M605108 group and 20.7 years for vehicle group) and was similar in the groups. The age distribution was similar in the groups with patients <- 30 years accounting for >- 90% (91.7% for 2.5% M605108 group and 91.2% for vehicle group). The total lesion counts (sum of inflammatory and non-inflammatory lesion counts), and the mean of lesion and non-inflammatory lesion counts at baseline was 61.1, 22.5, and 38.6 for the 2.5% M605108 group and 58.9, 21.6, and 37.4 for the vehicle group, respectively, showing no differences between the groups.

A total of 222 patients were randomly assigned to the 2.5% M605108 group (109 patients) or the vehicle group (113 patients), and all received the study drug. Of the 222 patients, 5 (2 in the 2.5% M605108 group, 3 in the vehicle group) discontinued the study and 217 completed the study (107 in the 2.5% M605108 group, 110 in the vehicle group). All patients who received the study drug were included in the full analysis set and the safety analysis set.

The incidence of adverse events was similar between the 2.5% M605108 group and the vehicle group (29.4% versus 23.9%). Of these, the incidence of drug-related adverse events was slightly higher in the 2.5% M605108 group compared with the vehicle group (11.9% versus 6.2%). Severity was mild in all but moderate in 2.8% of the 2.5% M605108 group and 1.8% of the vehicle group. No deaths occurred, and other serious adverse event was gastroenteritis in 1 patient (0.9%) in the 2.5% M605108 group, which was considered not related to the study drug. The incidence of adverse events leading to study drug discontinuation was 1.8% only in the 2.5% M605108 group. The incidence of adverse events corresponding to skin irritation was higher in the 2.5% M605108 group (18.3%) compared with the vehicle group (9.7%). Skin safety scores (scaling, erythema) shows that the majority of patients had no scaling (>- 95% patients) and no erythema (>- 90% patients) at each assessment time point with no clear difference between groups. No clinically significant changes were observed in laboratory values.

The least squares mean of percentage reduction in total lesion counts at Week 12, the primary endpoint, was 63.02% in the 2.5% M605108 group and 26.54% in the vehicle group. The difference between the groups (two-sided 95% confidence intervals) were 36.48% (26.28% to 46.68%), showing a significant reduction in total lesion counts in the 2.5% M605108 group than in the vehicle group. A reduction in the total lesion counts was observed from an early stage, with significant difference between the groups starting 2 weeks after treatment. The percentage reduction in inflammatory and non-inflammatory total lesion counts at Week 12, one of the secondary endpoints, indicated significant differences between the 2.5% M605108 and the vehicle groups, supporting the primary endpoint results.

This study demonstrated that 2.5% M605108 once-daily for 12 weeks was efficacious in the treatment of patients with acne vulgaris. Moreover, the regimen was considered well tolerated because the incidence of adverse events leading to study drug discontinuation was low and the severity of most adverse events was mild.

July. 15, 2022

https://www.jstage.jst.go.jp/article/jocd/39/4/39_600/_article/-char/ja

No

https://jrct.niph.go.jp/latest-detail/jRCT2031200251

Nishiura Tomoyuki

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

ctinfo@mii.maruho.co.jp

Clinical Trials Infomation

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

+81-75-325-3279

ctinfo@mii.maruho.co.jp

Complete

Dec. 16, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Patients with acne vulgaris

-Patients with concurrent presense of serious cardiac, hepatic, renal, plumonary, hematologic, or other diseases considered inappropriate for paticipation in the clinical study
-Patients with a history of hypersensitivity to investigational drug ingredients
-Pregnant or lactating women

Both

Acne vulgaris

Patients apply a sufficient quantity of benzoyl peroxide to cover the entire face (except the lips and around the eyes) once daily at night after they washed and dried their faces.

Percentage change in total lesion count from baseline to week 12

Percentage change in inflammatory lesion and non-inflammatory lesion counts from baseline to week 12

+81-3-5543-0196

none