Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination (READY-3)

Galderma

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines (GL); Lateral Canthal Lines (LCL)

Treatments: Biological: Placebo; Biological: botulinum toxin neuromodulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04247074

43QM1902

Details and patient eligibility

About

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.

Enrollment: 413 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female 18 years of age or older.
2. Moderate to severe LCL at maximum smile as assessed by the Investigator.
3. Moderate to severe LCL at maximum smile as assessed by the subject.
4. Moderate to severe GL at maximum frown as assessed by the Investigator.
5. Moderate to severe GL at maximum frown as assessed by the subject

Exclusion criteria

1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
2. Female who is pregnant, breast feeding, or intends to conceive a child during the study.
3. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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413 participants in 4 patient groups, including a placebo group

QM1114-DP in the LCL + Placebo in the GL

Experimental group

Description:

QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection

Treatment:

Biological: botulinum toxin neuromodulator

Biological: Placebo

Placebo in the LCL and GL

Placebo Comparator group

Description:

A buffered solution; Mode of administration: intramuscular injection

Treatment:

Biological: Placebo

Placebo in the LCL + QM1114-DP in the GL

Experimental group

Description:

QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection

Treatment:

Biological: botulinum toxin neuromodulator

Biological: Placebo

QM1114-DP in the LCL + GL

Experimental group

Description:

QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection

Treatment:

Biological: botulinum toxin neuromodulator