Treatment of Moderate to Severe Lateral Canthal Lines (READY-2)

Galderma

Status and phase: Completed; Phase 3

Conditions: Lateral Canthal Lines

Treatments: Biological: Placebo; Biological: botulinum toxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04249687

43QM1901

Details and patient eligibility

About

The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe LCL.

Enrollment: 303 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.

Exclusion criteria

1. Previous use of any Botulinum toxin treatment 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) or any botulinum toxin serotype.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

303 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

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

Treatment:

Biological: botulinum toxin

Placebo

Placebo Comparator group

Description:

A buffered solution; Mode of administration: intramuscular injection

Treatment:

Biological: Placebo