CompletedPhase 3

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

United States413 participantsStarted 2020-02-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown

Timeframe: Month 1

Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile

Timeframe: Month 1

Trial details

NCT IDNCT04247074

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-02

Results submitted2023-05-23

View on ClinicalTrials.gov More Glabellar Frown Lines (GL) trials