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

Galderma R&D25 enrolled

Overview

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

This was an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glabellar Frown Lines Canthal Lines

Interventions

QM1114-DPBIOLOGICAL

QM1114-DP

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Galderma Research Site

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Month 1

Data from ClinicalTrials.gov

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