Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines (READY-4)

Galderma

Status and phase: Completed; Phase 3

Conditions: Glabellar Lines; Lateral Canthal Lines

Treatments: Biological: botulinum toxin neuromodulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04225260

43QM1903

Details and patient eligibility

About

This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL).

Enrollment: 902 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female at least 18 years of age.

Exclusion criteria

• Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
• Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
• 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) or any botulinum toxin serotype.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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902 participants in 1 patient group

QM1114-DP in the LCL and the GL areas

Experimental group

Description:

The investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines.

Treatment:

Biological: botulinum toxin neuromodulator