臨床研究等提出・公開システム

A Phase 3, Multicenter, Double-blind, Randomized, Placebo controlled, Parallel group Study to Evaluate the Efficacy and Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines in Japanese Adults (A Study to Evaluate the Efficacy and Safety of MT10109L Compared with Placebo for the Treatment of Glabellar Lines in Japanese Adults)

A Phase 3, Multicenter, Double-blind, Randomized, Placebo controlled, Parallel group Study to Evaluate the Efficacy and Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines in Japanese Adults

Han Sueun

Medytox Inc.

626, Teheran-ro, Gangnam-gu, Seoul, Korea

sehan@medytox.com

Rosario Chikako

Parexel International Inc.

Kayabacho Tower, 1-21-2, Shinkawa, Chuo-ku, Tokyo, 104-0033

+81-80-8929-3137

Clinicaltrial-registration@parexel.com

Recruiting

Mar. 31, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Participant must be between >=18 years and <65 years of age and considered to be an adult in her/his local jurisdiction at the time of signing the informed consent.
2. Japanese participant is with moderate to severe GL at maximum frown (as assessed by the investigator) using the MGLS.
3. Participant is male or female.
4. Contraceptive use by male or female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
5. Participant is capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
6. Written ICF has been obtained from the participant prior to any study-related procedures.
7. Written documentation has been obtained in accordance with the relevant Japan and local privacy requirements, where applicable.
8. Ability to follow study instructions and likely to complete all required visits.

1. Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
2. Infection or skin disorder at the injection sites.
3 Any uncontrolled systemic disease.
4. Recent history of alcohol or drug abuse based on the investigator's judgment.
5. Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
6. Any condition which precludes a participant's ability to comply with study requirements, including completion of the study visit or inability to read, understand.
7. The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

Both

moderate to severe GL (Glabellar Lines)

participants can receive up to 4 study interventions

The proportion of participants who achieve a rating of none/minimal or mild at maximum frown at Day 30 according to investigator assessment using the MGLS

- Proportion of participants who achieve a rating of none/minimal or mild at maximum frown at Day 60, Day 90 after the first treatment according to investigator assessment using the MGLS

+81-3-6777-1490

Jan. 24, 2025

No

Plan to share IPD data was set to "No", but it is currently not supported.

none