New Technique and Product for Chin Enhancement

NCT07193199 | Active Not Recruiting

• 1 other identifier: PRO-2025-RS
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aesthetic

Keywords

Hyaluronic Acid; Fillers; Facial Assessment; Chin Augmentation

Outcome Measures

Primary Outcomes (2)

• 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".

  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).

  Baseline to Month 12

Secondary Outcomes (2)

• Frequency of post-injection reactions including pain and discomfort during treatment, immediately after treatment, and at 14 days post-treatment

  Baseline to Month 12

• Frequency of physician-reported and participant-reported adverse events (AEs) at any visit post-injection

  Baseline to Month 12

Other Outcomes (6)

• Change perimental tissue depth assessed by CT imaging at Months 6 and 12 compared to baseline

  Baseline, Month 6, Month 12

• Correlation between hyaluronic acid (HA) volume injected and the incidence and/or severity of HA-related tissue changes in the chin at Months 6 and 12

  Baseline, Month 6, Month 12

• Correlation between aesthetic improvement and degree of tissue changes in the chin area from Baseline to Month 12

  Baseline to Month 12

Study Arms (1)

Revanesse Sculpt+

OTHER

Twenty-one (n = 21) male and female participants aged 18 years or older, including seven (n = 7) participants within each of the Allergan Chin Retrusion Scale(ACRS) categories corresponding to mild, moderate, and severe, based on the assessment of the Treating Investigator, will receive Revanesse Sculpt+ for the treatment of mild to severe chin retrusion at the Baseline visit (Visit 2) and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator.

Device: Revanesse Sculpt+

Interventions

Revanesse Sculpt+ DEVICE

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.

Revanesse Sculpt+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants without chin retrusion at Screening, per the ACRS1 ;
• 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;
• Previous tissue revitalization therapy in the treatment area (i.e., the lower face) within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
• Previous facial surgery, including liposuction;
• Lifetime history of permanent implants in the treatment region (i.e., the lower face) including but not limited to dental implants;
• Lifetime history of semi-permanent dermal fillers in the treatment region (i.e., the lower face);
• History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
• Active facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes zoster or any other facial condition that may increase the risk of cutaneous penetration of infective agents;
• Scars, deformities, piercing, or tattoos in the treatment areas;

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc.

Montreal, Quebec, H3Z 1C3, Canada

Location

Study Officials

• Andreas Nikolis, MD, PhD

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: September 25, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): May 24, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)