Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants For the Improvement of Skin Quality
Lead Sponsor:
AbbVie
Conditions:
Skin Quality Deficit
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many in...
Eligibility Criteria
Inclusion
- Fitzpatrick skin types II-IV
- Participants' FACE-Q Satisfaction with Skin Scale scores must meet the following criteria:
- Participants must have FACE-Q Satisfaction with Skin Scale sum of raw scores of 39 or less
- Participants must score "Very Dissatisfied" or "Somewhat Dissatisfied" on the following two questions:
- How hydrated your facial skin looks?
- How radiant your facial skin looks?
Exclusion
- Any skin condition in the face area that might not be suitable for injection
- Uncontrolled systemic disease
- History of anaphylactic shock, or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study
- Active autoimmune disease
- Tendency to develop hypertrophic scarring
- Currently undergoing chemotherapy/radiotherapy
- Is undergoing orthodontia before enrollment or is planning to undergo it during the study
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06547125
Start Date
July 18 2024
End Date
February 1 2026
Last Update
August 1 2025
Active Locations (6)
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1
China-Japan Friendship Hospital /ID# 260959
Beijing, Beijing Municipality, China, 100029
2
Peking University First Hospital /ID# 260957
Xicheng District, Beijing Municipality, China, 100034
3
Nanjing Drum Tower Hospital /ID# 260950
Nanjing, Jiangsu, China, 210008
4
Zhongda Hospital Southeast University /ID# 260951
Nanjing, Jiangsu, China, 210009