New Technique and Product for Chin Enhancement (NCT07193199) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
New Technique and Product for Chin Enhancement
Canada21 participantsStarted 2025-06-02
Plain-language summary
The use of hyaluronic acid (HA) fillers for soft tissue augmentation offers a valuable treatment modality for the correction of chin retrusion (i.e., when the chin appears to be set back or further back than normal in relation to the rest of the face). Their use is well-tolerated and provides satisfactory aesthetic results by improving facial balance and projection. Although the efficacy of hyaluronic acid HA fillers for chin augmentation has been established, the specific anatomy of the region may lead to adverse events. More specifically, certain fillers with strong integration characteristics may lead to product migration, while others with poor integration characteristics may lead to palpable deformities and distortion of the surrounding injection tissues.
Using a filler that has a high concentration of hyaluronic acid, a medium level of firmness and low water absorption may offer an effective option for treating this indication while minimizing certain adverse events. In addition, using consistent, standardized injection techniques can help achieve an ideal result.
We believe that the use of a novel HA gel (Revanesse Sculp+) for the chin, with a high concentration of HA, a moderate firmness and low water absorption, will perform better than historical controls with firmer properties in the management of chin retrusion.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At the time of consent, male and female participants 18 years of age and older;
✓. Participants with established chin retrusion at Baseline (a score of minimal, moderate or severe; based on the Treating Investigator's Allergan Chin Retrusion Scale(ACRS)1 assessment;
✓. Accepted the obligation not to receive any other facial procedures throughout the study duration;
✓. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
✓. No previous lower face fillers for 12 months prior to this study;
✓. Capable of providing informed consent;
✓. Willing to undergo scheduled CT scans as part of the study design;
✓. Females of childbearing potential agree to take a scheduled urinary pregnancy test (UPT) prior to treatment administration.
Exclusion criteria
✕. Participants without chin retrusion at Screening, per the ACRS1 ;
What they're measuring
1
Frequency of participants graded as at least 'improved' on the Global Aesthetic Improvement Scale (GAIS) by a blinded evaluator at baseline to Month 12
Timeframe: Baseline to Month 12
2
Proportion of participants with ≥1 grade-point improvement from baseline in chin retrusion, as assessed by a blinded evaluator using the CCPS and/or ACRS
✕. Participants with extreme chin retrusion at Screening as per the ACRS1;
✕. Current Pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\];
✕. Hypersensitivity to Revanesse products, hyaluronic acid filler or amide local anesthetics;
✕. Participants presenting with porphyria or any other liver diseases;
✕. Inability to comply with follow-up and abstain from facial injections during the study period;
✕. Heavy smokers, classified as smoking more than 12 cigarettes per day;
✕. History of severe or multiple allergies manifested by anaphylaxis, since drug allergies might preclude optimal management of complications;