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Completed

NCT Number: NCT05146999

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

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

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Key information

Conditions

Glabellar Frown Lines

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma Research Site, Homewood, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QM1114-DP

Biological

QM1114-DP

Placebo

Biological

Placebo

Primary outcomes

  1. Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1

    Time frame: 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 outcomes

  1. Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects With Moderate to Severe Glabellar Lines

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 7, 2021
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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