Phase 3 N=413 Randomized Quadruple-blind Treatment

Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination

Glabellar Frown Lines (GL) · Lateral Canthal Lines (LCL)

Bottom Line

View on ClinicalTrials.gov: NCT04247074 ↗

Enrolled (actual)

413

Serious AEs

0.7%

Results posted

Sep 2023

Primary outcome: Primary: Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown — 0; 75; 78 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: botulinum toxin neuromodulator (Biological); Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown	0; 75; 78	<0.001 sig
PRIMARY Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile	53; 0; 59	<0.001 sig
SECONDARY Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown	1; 97; 102	<0.001 sig
SECONDARY Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.	89; 10; 89	<0.001 sig

Summary

This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.

Eligibility Criteria

Inclusion Criteria

Male or female 18 years of age or older.
Moderate to severe LCL at maximum smile as assessed by the Investigator.
Moderate to severe LCL at maximum smile as assessed by the subject.
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.
Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04247074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.