N/A
N=148
Restylane Defyne for Correction of Chin Retrusion
Chin Retrusion
Bottom Line
View on ClinicalTrials.gov: NCT03597256 ↗Enrolled (actual)
148
Serious AEs
2.2%
Results posted
Jun 2024
Primary outcome: Primary: 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) — 81.1; 5.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Defyne (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
81.1; 5.4 | — |
| SECONDARY Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) |
83.5; 78.1; 84.1; 72.7; 71.7; 62.5 | — |
| SECONDARY Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator |
92.8; 0; 84.4; 0; 80.4; 0 | — |
Summary
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03597256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.