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

Galderma R&D132 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

132

Conditions

Glabellar Frown Lines

Interventions

QM1114-DPBIOLOGICAL

QM1114-DP

PlaceboBIOLOGICAL

Placebo

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (9)

Galderma Research Site

Homewood, Alabama, United States

Galderma Research Site

Manhattan Beach, California, United States

Galderma Research Site

Vista, California, United States

Galderma Research Site

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: At Month 1

Secondary Outcomes

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

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.

Time frame: At Days 0 through 7 post-treatment

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

Time frame: From Day 1 through Month 12

Data from ClinicalTrials.gov

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