NCT04631263CompletedNot Applicable
A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multi-center Study to Evaluate Effectiveness and Safety of GP0109 for Augmentation and Correction of Retrusion in the Chin Region
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 140
- Locations
- 10
- Primary Endpoint
- Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator
Study Overview
Brief Summary
Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GP0109 for augmentation and correction or retrusion in the chin region in Canada
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •subject willing to comply with the requirements of the study
- •subject intent to receive treatment for augmentation and correction of retrusion in the chin region
- •subject with mild or moderate (grade 1 or 2) on the GCRS
Exclusion Criteria
- •subjects presenting with know allergy to HA (hyaluronic acid) filler or amide local anesthetics
- •subjects with any previous facial surgery below the nasal line or previous HA filler or collagen below the nasal line within 12 months
- •subjects in any other interventional clinical study within 30 days before baseline
Outcomes
Primary Outcomes
Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator
Time Frame: 3 months after baseline
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (10)
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