Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

Phase 3

Completed

• Conditions: Glabellar Lines; Lateral Canthal Lines

• Registration Number: NCT04225260
• Lead Sponsor: Galderma R&D

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-01-27
• Status Verified: 2020-07
• Primary Completion: 2021-04-12
• Study Completion: 2021-05-21
• Disposition First Submitted: 2021-05-26
• Disposition First Submitted QC: 2021-05-26
• Disposition First Posted: 2021-05-28
• Results First Submitted: 2023-05-23
• Results First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Results First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 902

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown	Week 4	4-point scale
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile	Week 4	4-point scale

Trial Locations

Locations (30)

Total Skin and Beauty Dermatology Center, PC; 🇺🇸 Birmingham, Alabama, United States

Investigate MD, LLC.; 🇺🇸 Scottsdale, Arizona, United States

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Rejuva Medical Aesthetics, LLC; 🇺🇸 Los Angeles, California, United States

Westside Aesthetics; 🇺🇸 Los Angeles, California, United States

Marcus Facial Plastic Surgery; 🇺🇸 Redondo Beach, California, United States

The Maas Clinic Research Center; 🇺🇸 San Francisco, California, United States

ArteMedica; 🇺🇸 Santa Rosa, California, United States

AboutSkin Research, LLC; 🇺🇸 Greenwood Village, Colorado, United States

Modern Dermatology PC; 🇺🇸 Westport, Connecticut, United States

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