Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines

NCT05148000 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 43QM2107
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study to assess aesthetic improvement following treatment with QM1114-DP.

Conditions

Glabellar Frown Lines; Canthal Lines

Outcome Measures

Primary Outcomes (2)

• Responders Rate Using the Global Aesthetic Improvement Scale (GAIS) at Maximum Frown (Glabellar Lines)

  The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your glabellar lines (lines between your eyebrows) at maximum frown compared with immediately before the injection?". Participants were then instructed to select on rating that best describes the degree to which the appearance of their glabellar lines at maximum frown has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum frown.

  Month 1

• Responders Rate Using the GAIS at Maximum Smile (Lateral Canthal Lines)

  The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your lateral canthal lines (crow's feet) at maximum smile compared with immediately before the injection". Participants were then instructed to select on rating that best describes the degree to which the appearance of their lateral canthal lines at maximum smile has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum smile.

  Month 1

Study Arms (1)

QM1114-DP

EXPERIMENTAL

QM1114-DP

Biological: QM1114-DP

Interventions

QM1114-DP BIOLOGICAL

QM1114-DP

QM1114-DP

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 bilaterally symmetrical LCL as assessed by the investigator
• Moderate to severe GL at maximum frown as assessed by the Investigator

You may not qualify if:

• Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
• Female who was pregnant, breast feeding or intended to conceive a child during the study.
• Known allergy to hypersensitivity or any component of the Investigational product

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Galderma Research Site

New York, New York, 10021, United States

Location

Results Point of Contact

• Title: Galderma Clinical Project Manager
• Organization: Galderma

aestheticclinicaltrials@galderma.com

+1 817-961-5000

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label single site study for treatment of GL and LCL with single treatment of QM1114-DP

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: December 7, 2021
• Study Start: January 23, 2023
• Primary Completion: March 31, 2023
• Study Completion: June 23, 2023
• Last Updated: May 29, 2026
• Results First Posted: May 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)