NCT03597256CompletedNot Applicable
A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Defyne for Correction of Chin Retrusion
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)
Study Overview
Brief Summary
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participated with signed and dated informed consent form.
- •Men or women aged 18 years of age or older of Chinese origin.
- •Subjects who were seeking augmentation therapy for chin retrusion.
- •GCRS score of 1 or 2 as assessed by the Blinded Evaluator
Exclusion Criteria
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
- •Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
- •History of severe or multiple allergies, manifested by anaphylaxis.
- •Previous facial surgery, or tissue revitalization treatment with laser or light, needling, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion below the level of the horizontal line from subnasale within 6 months before treatment.
- •Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
- •Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the horizontal line from subnasale.
- •Other condition that was preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
Outcomes
Primary Outcomes
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)
Time Frame: At Month 6
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method.
Secondary Outcomes
- Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)(Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment)
- Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator(At Week 4 and Months 3, and 6)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour DeficiencyMidface Volume DeficitNCT03097783Galderma R&D169
Recruiting
Not Applicable
TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese AdultsInfraorbital HollowsNCT06749587Teoxane SA260
Completed
Not Applicable
Effectiveness and Safety of Restylane Contour in the Treatment of Temple HollowingTemporal HollowingNCT05691972Galderma R&D225
Completed
Not Applicable
Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following Treatment for Correction of Wrinkles in Décolletage Area in the Investigational Study 43USRV1906WrinkleNCT04717934Galderma R&D211
Completed
Not Applicable
Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial FoldsNasolabial FoldsNCT03753152Medy-Tox370