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

NCT05146999 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 43QM2106
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 9

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

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) 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).

  At Month 1

Secondary Outcomes (2)

• Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card

  At Days 0 through 7 post-treatment

• Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12

  From Day 1 through Month 12

Study Arms (2)

Active arm - QM1114-DP

ACTIVE COMPARATOR

a Botulinum Toxin Type A (BoNT-A)

Biological: QM1114-DP

Inactive arm - Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

QM1114-DP BIOLOGICAL

QM1114-DP

Active arm - QM1114-DP

Placebo BIOLOGICAL

Placebo

Inactive arm - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (9)

Galderma Research Site

Homewood, Alabama, 35209, United States

Location

Galderma Research Site

Manhattan Beach, California, 90266, United States

Location

Galderma Research Site

Vista, California, 92083, United States

Location

Galderma Research Site

Coral Gables, Florida, 33146, United States

Location

Galderma Research Site

Hunt Valley, Maryland, 21030, United States

Location

Galderma Research Site

Omaha, Nebraska, 68144, United States

Location

Galderma Research Site

Chapel Hill, North Carolina, 27517, United States

Location

Galderma Research Site

Pflugerville, Texas, 78660, United States

Location

Galderma Research Site

Spring, Texas, 77388, United States

Location

Results Point of Contact

• Title: Felipe Weinberg, MD, MPH
• Organization: Galderma Research & Development, LLC

aestheticclinicaltrials@galderma.com

817-961-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: December 7, 2021
• Study Start: May 9, 2022
• Primary Completion: October 28, 2022
• Study Completion: September 1, 2023
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)