A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants in China For the Improvement of Skin Quality
- Conditions
- Skin Quality Deficit
- Registration Number
- NCT06547125
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria:<br><br> - Fitzpatrick skin types II-IV<br><br> - Participants' FACE-Q Satisfaction with Skin Questionnaire scores must meet the<br> following criteria:<br><br> - Participants must have FACE-Q Satisfaction with Skin Questionnaire sum of raw<br> scores of 39 or less<br><br> - Participants must score Very Dissatisfied or Somewhat Dissatisfied on the<br> following two questions:<br><br> - How hydrated your facial skin looks?<br><br> - How radiant your facial skin looks?<br><br>Exclusion Criteria:<br><br> - Any skin condition in the face area that might not be suitable for injection<br><br> - Uncontrolled systemic disease<br><br> - History of anaphylactic shock, or allergy to lidocaine (or any amide-based<br> anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is<br> planning to undergo desensitization therapy during the study<br><br> - Active autoimmune disease<br><br> - Tendency to develop hypertrophic scarring<br><br> - Currently undergoing chemotherapy/radiotherapy<br><br> - Is undergoing orthodontia before enrollment or is planning to undergo it during the<br> study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Responder Status for Evaluating Investigator's (EI) Live Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area Using the Global Aesthetic Improvement Scale (GAIS);Number of Participants with Adverse Events (AEs)
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Responder Status for Participant's Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area using GAIS;Percentage of Participants Achieving Responder Status for Treating Investigator's (TI) Assessment of Global Aesthetic Improvement of Skin Quality on the Treatment Area using GAIS;Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Questionnaire;Change from Baseline in Treatment Area Skin Hydration Measurement;Percentage of Participants with Responder Status based on EI's Live Assessments of Hydration Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Hydration;Percentage of Participants with Responder Status based on EI's Live Assessments of Radiance Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Radiance