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A phase III study to evaluate the efficacy and safety of M605110 in patients with acne vulgaris

A phase III study to evaluate the efficacy and safety of M605110 in patients with acne vulgaris

42

The patients were 24 males and 18 females, with a mean age (standard deviation, SD) of 27.8 (10.8) years. The mean of total lesion count (SD) was 49.6 (14.7), with the mean of inflammatory and non-inflammatory lesion count (SD) being 19.4 (6.9) and 30.2 (10.7), respectively. The evaluation site was the chest for 2 patients and the back for 40 patients.

Among the patients who consented to participate in the clinical study, 43 were enrolled, 42 received the Investigational products (IP), and 41 completed the study.

The incidence of adverse events (AEs) was 50.0%. Except for one AE of moderate in severity (not related to the IP), all AEs were mild. All AEs were either recovered or recovering, except for one AE of unrecovered eczema (not related to the IP). The incidence of AEs related to the IP was 21.4%. No deaths or serious adverse events were observed. There were no AEs leading to discontinuation or interruption of the IP. AEs leading to dose reduction were observed in two patients, one of which (dermatitis contact) was related to the IP. The incidence of AEs corresponding to skin irritation symptoms was 28.6%, of which 19.0% were related to the IP. The only AE that was corresponding to a systemic hypersensitivity reaction was pruritus, which occurred in one patient and was not related to the IP. No clinically significant changes were observed in laboratory test results. Regarding skin safety scores for both scales and erythema, the proportion of patients scoring 0 was over 90% at baseline and on each evaluation day after the administration of the IP.

For the primary endpoint, the mean of percentage reduction of total lesion count at Week 12 (two-sided 95% confidence interval [95% CI]) was 65.16% (56.41% to 73.91%), confirming the treatment of 5% M605110 reduced lesion count on the trunk. Results from the secondary endpoints showed that both inflammatory lesion count (the mean of percentage reduction of lesion count at Week 12 [95% CI]: 73.27% [66.25% to 80.28%]) and non-inflammatory lesion count (60.38% [48.37% to 72.39%]) were reduced. Additionally, it was found that each type of lesions count decreased over time from Week 2. Compared to baseline, the percentage of patients who achieved an Investigator's Global Assessment (IGA) score improvement of more than 2 grades and an IGA score that reached 0 or 1 at Week 12, increased over time, being 2.7% at Week 2 and 29.7% at Week 12.

As a short contact therapy for patients with acne vulgaris on the trunk (chest or back), 5% M605110 was applied and then washed off after 5 to 10 minutes, once daily for 12 weeks. The results showed that each type of lesion count decreased and tolerability was favorable.

July. 22, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031220334

Tomoyuki Nishiura

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

ctinfo@mii.maruho.co.jp

Clinical Trials Information -

Maruho Co.,Ltd. Kyoto R&D Center

3 chudoji Awatacho, Shimogyo-ku, Kyoto

+81-75-325-3279

ctinfo@mii.maruho.co.jp

Complete

Sept. 13, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients with Acne vulgaris 9 to 49 years old

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

Both

Acne vulgaris

Apply an appropriate amount of M605110 once a day.

Percentage change in total lesion count

+81-355430196

Aug. 31, 2022

none