Clinical trial NCT03597256: Restylane Defyne for Correction of Chin Retrusion
Official title: A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Defyne for Correction of Chin Retrusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chin Retrusion
Keywords: Hyaluronic acid
Chin Retrusion
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.


Eligibility criteria: Inclusion Criteria:

1. Participated with signed and dated informed consent form.
2. Men or women aged 18 years of age or older of Chinese origin.
3. Subjects who were seeking augmentation therapy for chin retrusion.
4. GCRS score of 1 or 2 as assessed by the Blinded Evaluator

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
2. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
3. History of severe or multiple allergies, manifested by anaphylaxis.
4. 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.
5. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
6. 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.
7. 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.

Primary outcomes:
measure: 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)
timeFrame: At Month 6
Secondary outcomes:
measure: Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)
timeFrame: 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
measure: Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator
timeFrame: At Week 4 and Months 3, and 6
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Galderma Research Site
state: Shanghai
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References: