N/A
N=192
A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
Chin Retrusion
Bottom Line
View on ClinicalTrials.gov: NCT02833077 ↗Enrolled (actual)
192
Serious AEs
6.5%
Results posted
Jul 2020
Primary outcome: Primary: Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score — 56.3; 27.5 percentage of participants — p=0.0019
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- JUVÉDERM VOLUMA® XC (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score |
56.3; 27.5 | 0.0019 sig |
| SECONDARY Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire |
35.7; 35.3; 35.6; -3.3 | <.0001 sig |
| SECONDARY Percentage of Participants Improved or Much Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) for the Chin Area As Assessed by the Evaluating Investigator |
91.2; 19.5 | — |
| SECONDARY Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants |
87.3 | — |
Summary
This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.
Eligibility Criteria
Inclusion Criteria
- Chin retrusion
- In good general health
Exclusion Criteria
- Permanent facial implants on the face and/or neck
- Received fat injections below the nose
- Tattoos, piercings, beard, mustache, and/or scars on the face below the nose
- Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years
- Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years
- Received dermal filler injections in the lips or in the mouth area in the last 12 months
- Undergone mesotherapy or cosmetic treatment (e.g., laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck in the last 6 months
- Received botulinum toxin treatment below the nose in the last 6 months
Data sourced from ClinicalTrials.gov (NCT02833077). 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.