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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Revanesse Sculpt+ is approved and commercially available for use in Canada and is manufactured by Prollenium Technologies Inc. All study participants will receive Revanesse Sculpt+ for the treatment of mild to severe chin retrusion.
Erevna Innovations Inc.
Montreal, Quebec, Canada
Frequency of participants graded as at least 'improved' on the Global Aesthetic Improvement Scale (GAIS) by a blinded evaluator at baseline to Month 12
Frequency of participants having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS), as graded by a blinded evaluator. The Global Aesthetics Improvement Scale (GAIS) is a five-point Likert scale, categorized as "worse", "no change", "improved", "much improved" and "very much improved".
Time frame: Baseline to Month 12
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
The Croma Chin Projection Assessment Scale (CCPS) is a a validated 5-point assessment tool for the projection of the chin using a vertical line from pogonium through the lower vermilion boarder in front of the labiomental crease. It grades chin retrusion from 0 (ideal chin projection) to 4 (very severe retrusion). The Allergan Chin Retrusion Scale (ACRS) is a validated 5-point assessment tool for chin retrusion using the midpoint of the chin and the lower vermillion boarder. It grades chin retrusion from 0 (no retrusion) to 4 (extreme chin retrusion).
Time frame: Baseline to Month 12
Frequency of post-injection reactions including pain and discomfort during treatment, immediately after treatment, and at 14 days post-treatment
Frequency of post injection reactions including pain and discomfort (generalized, during chewing, talking, and/or kissing as applicable) during treatment, immediately after treatment and 14 days following treatment.
Time frame: Baseline to Month 12
Frequency of physician-reported and participant-reported adverse events (AEs) at any visit post-injection
Frequency of post injections reactions including physician-reported and participant-reported adverse events (AEs) at any visit.
Time frame: Baseline to Month 12
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