Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines

Phase 3

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Biological: QM1114-DP; Biological: Placebo

• Registration Number: NCT05146999
• Lead Sponsor: Galderma R&D

Brief Summary

The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-31
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-07
• Study Start: 2022-05-09
• Primary Completion: 2022-10-28
• Study Completion: 2023-09-01
• Results First Submitted: 2024-08-30
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Results First Posted: 2024-10-21
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Male or Female 18 years or older
• Moderate to severe GL at maximum frown as assessed by the Investigator
• Moderate to severe GL at maximum frown as assessed by the subject

Exclusion Criteria

• Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
• Female who is pregnant, breast feeding or intends to conceive a child during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active arm - QM1114-DP	QM1114-DP	a Botulinum Toxin Type A (BoNT-A)
Inactive arm - Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1	At Month 1	Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded "improved," "much improved," or "very much improved" on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card	At Days 0 through 7 post-treatment	Following treatment at baseline, participants were asked to record their assessment of study treatment response in a diary card on Days 0 through 7. They were asked to respond "yes" or "no" to the following question: "Since being injected, have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows) when you frown?" Response to treatment effect given by a Participant on first day as "yes" to the diary question.
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12	From Day 1 through Month 12	Participant assessment From Day 1 through Month 12 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a Participant who responded "improved," "much improved," or "very much improved" on the GAIS at maximum frown. This analysis is based on observed cases.

Trial Locations

Locations (1)

Galderma Research Site; 🇺🇸 Spring, Texas, United States