Japanease

Dec. 16, 2020

Dec. 16, 2020

jRCT2031200251

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

Nishiura Tomoyuki

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

+81-75-325-3279

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

Nov. 26, 2020

200

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

none

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

12age old over
49age old under

Both

Acne vulgaris

Patients apply a sufficient quantity of the assigned drug 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

Pending

Maruho co.,Ltd
Doujin Memorial Medical Foundation, Meiwa Hospital IRB
1-18, Kandasudacho, Chiyoda-ku, Tokyo

+81-3-5543-0196

jimukyoku@smo-msr.co.jp
Approval

Nov. 11, 2020

No