Treatment of Moderate to Severe Glabellar Lines (READY-1)

Galderma

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Biological: botulinum toxin; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04249583

43QM1602

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 GL.

Enrollment: 300 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 GL at maximum frown as assessed by the Investigator.
3. 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) or any botulinum toxin serotype.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

300 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