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A Phase III, Randomized, Placebo-controlled, Investigator-blinded, Parallel, Multi-Center Study of M121101 in patients with pincer nail

A Phase III study of M121101 in patients with pincer nail

79

There were no differences in participant characteristics between the M121101 group and the vehicle group. The proportion of female participants was higher than male participants with 77.2% (61 of 79 participants). The overall mean age was 51.9 years. The mean distal narrowed nail width (dNNW) ratio and nail plate thickness on the first day of treatment was 40.22% and 1.39 mm, respectively.

Of the patients who signed informed consent to participate in the study, 80 were randomized and 79 received the study drug. Sixty participants completed the study: 34 in the M121101 group and 26 in the vehicle group. Of the 19 participants who discontinued the study, 6 were in the M121101 group and 13 were in the vehicle group, with a higher number of discontinuations in the vehicle group than in the M121101 group. Reasons for discontinuation were adverse events in 9 participants (1 in the M121101 group; 8 in the vehicle group), coming off of the device during treatment period 1 in 9 participants (5 in the M121101 group; 4 in the vehicle group), and the participant's request in 1 participant in the vehicle group due to COVID-19.

The incidence of adverse events was 37.5% (15 of 40) in the M121101 group and 56.4% (22 of 39) in the vehicle group, with a lower incidence in the M121101 group. No drug-related adverse events occurred in the M121101 group but in the vehicle group (15.4%, 6 of 39). The incidence of adverse events related to the overcurvature-correcting device (the device) was 15.0% (6 of 40) in the M121101 group and 38.5% (15/39) in the vehicle group, with a higher incidence in the vehicle group. Severity was mild in all participants, except severe (breast cancer) in one participant in the M121101 group and moderate (tendonitis and tenosynovitis) in one participant each in the groups. No deaths occurred. One participant experienced a serious adverse event (breast cancer) in the M121101 group, which was not related to the study drug or the device. The incidence of significant adverse events was higher in the vehicle group, 5.0% (2 of 40) in the M121101 group and 25.6% (10 of 39) in the vehicle group, all of which were mild in severity. Of these, the incidence of inflammation around nail (PT: paronychia) treated with the study drug was low at 5.0% (2 of 40) in the M121101 group and 2.6% (1 of 39) in the vehicle group. Adverse events requiring the device to be removed occurred in 23.1% (9 of 39) in the vehicle group only. There were no adverse events that required removal of the study drug before 24 hours (acceptable range, 21-27 hours) after study drug application.

The primary endpoint, achievement of a 70% dNNW rate at Visit3 (Day 8 of the device attached), was 47.5% (19/40) in the M121101 group and 25.6% (10/39) in the vehicle group. The estimated between-group differences (95%CI) was 21.9% (0.6% to 43.1%), which was significantly higher in the M121101 group compared with the vehicle group (P = 0.0439). As a secondary endpoint, the number of days until the rate of 50% or less was assessed in participants who transitioned from Visit3 (Day 8) to treatment period 4 after removal of the device. The proportion of participants with the rate of 50% or less by Day 28 was 5.6% (1 of 18) in the M121101 group and 60.0% (6 of 10) in the vehicle group. The proportion of participants with the of 50% or less by study completion (Day 84) was 11.1% (2 of 18) in the M121101 group and 60.0% (6 of 10) in the vehicle group, indicating the corrective effect of the pincer nail tended to be maintained in the M121101 group over a longer period of the time compared with the vehicle group. Other secondary endpoints also showed a tendency of higher improvement in the M121101 group than in the vehicle group.

This study showed an earlier correction of the pincer nail with combination therapy of this drug and the device in patients with the pincer nail. Moreover, in follow-up for up to 12 weeks after removal of the device, the nail correction efficacy tended to be maintained for a longer period of the time with the combination therapy. Neither adverse events related to M121101 nor those requiring removal of the overcurvature-correcting device occurred in the M121101 group, indicating M121101 had no safety issues.

Mar. 15, 2024

Dec. 05, 2023

https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.17010

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031200264

Nishiura Tomoyuki

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

ctinfo@mii.maruho.co.jp

Infomation Trials Clinical

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

+81-75-325-3279

ctinfo@mii.maruho.co.jp

Complete

Dec. 24, 2020

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

Pincer nail patients

(1)Patients with complications of any of ingrown nail, onychomycosis, nail psoriasis, onychogryphosis, and pachyonychia at the application site
(2)Patients with a nail plate thickness of less than 1 mm at the application site

Both

Pincer nail

single application

Distal nail width narrowing rate

Adverse events

+81-3-5366-3006

Sept. 18, 2020

none