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

Galderma

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Biological: Placebo; Biological: QM1114-DP

Study type: Interventional

Funder types: Industry

Identifiers

NCT05146999

43QM2106

Details and patient eligibility

About

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

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 2 patient groups, including a placebo group

Active arm - QM1114-DP

Active Comparator group

Description:

a Botulinum Toxin Type A (BoNT-A)

Treatment:

Biological: QM1114-DP

Inactive arm - Placebo

Placebo Comparator group

Treatment:

Biological: Placebo