Clinical trial NCT03624816: A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion
Official title: A Randomized, No-treatment Controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Defyne in the Chin for Augmentation and Correction of Chin Retrusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chin Retrusion
Chin Augmentation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 140
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the effectiveness of Restylane Defyne for chin augmentation and correction of chin retrusion by demonstrating the superiority in responder rates relative to no treatment.

Detailed description: This was a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Defyne in the chin for augmentation and correction of chin retrusion.

This study was designed to enroll and randomize approximately 140 subjects in a 3:1 ratio of treatment to Restylane Defyne or no-treatment-control, including at least 21 subjects of Fitzpatrick skin type IV through VI. All randomized subjects were to have a Galderma Chin Retrusion Scale (GCRS) score of 1 (Mild) or 2 (Moderate).

Eligible subjects randomized to receive treatment were injected by the Treating Investigator at Day 1. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product was injected to achieve optimal correction of the chin, in the opinion of the Treating Investigator and subject. Optimal appearance was defined as at least 1 GCRS grade improvement from baseline and the best correction that could be achieved as agreed by the Treating Investigator and the subject.

At the 48-week visit, after all study procedures for the visit were completed, treated subjects had the option of receiving an additional treatment if optimal aesthetic improvement was not maintained with Restylane Defyne. Non-treated control subjects also had the option of receiving treatment with Restylane Defyne in the chin at Week 48. If an optional treatment was performed, a safety follow-up visits were scheduled

Eligibility criteria: Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, 22 years of age or older, seeking chin augmentation or correction of retrusion

Exclusion Criteria:

* Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
* Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents

Primary outcomes:
measure: Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale
timeFrame: 12 weeks after baseline
Secondary outcomes:
measure: Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12)
timeFrame: 12 weeks after last injection
measure: Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion
timeFrame: 24, 36, and 48 weeks after last injection
measure: Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale
timeFrame: 12, 24, 36, and 48 weeks after last injection
measure: Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24)
timeFrame: 24, 36, and 48 weeks after last injection
measure: Evaluate Volume Change in the Treated Area Using 3D Imaging
timeFrame: 12, 24, 36, and 48 weeks after last injection
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Westside Aesthetics
state: California
city: Manhattan Beach
country: United States
facility: Ablon Skin Institute and Research Center
state: California
city: Redondo Beach
country: United States
facility: Marcus Facial Plastic Surgery
state: California
city: Vista
country: United States
facility: Moradi M.D.
state: California
city: Coral Gables
country: United States
facility: Skin Research Institute, LLC
state: Florida
city: New Orleans
country: United States
facility: Etre Cometic Dermatology and Laser Center
state: Louisiana
city: Chevy Chase
country: United States
facility: WIDLS Chevy Chase
state: Maryland
city: Hunt Valley
country: United States
facility: Maryland Laser Skin and Vein Institute
state: Maryland
city: New York
country: United States
facility: Union Square Laser Dermatology
state: New York
city: Wilmington
country: United States
facility: Wilmington Dermatology and Laser Center
state: North Carolina
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute
state: Texas
Study officials:
References: