Status:
COMPLETED
A Study to Assess Adverse Events and Change in Disease Activity of JUVÉDERM® VOLITE™ XC Injectable Gel for Change in Neck Appearance in Adult Participants
Lead Sponsor:
AbbVie
Conditions:
Neck Lines
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief Summary
The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed...
Eligibility Criteria
Inclusion
- Participants in general good health as determined by Treating Investigator's judgment, including no known active pandemic infection.
- Participants seeking improvement of transverse neck lines.
- Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment.
Exclusion
- Neck deformity or significant skin laxity with severe redundant folds.
- Significant skin pigmentation disorders or discoloration in the neck area that would interfere with the visual assessment of the neck area.
- Current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the neck.
- Tendency to develop hypertrophic scarring.
- History of thyroid cancer, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area.
- Permanent soft tissue fillers in the neck area.
- Semi-permanent soft tissue fillers in the neck area within 2 years before enrollment.
- HA fillers or autologous fat in the neck area within 12 months before enrollment.
- Mesotherapy, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, microneedling, laser, or other cosmetic procedures in the neck area within 12 months before enrollment.
- Botulinum toxin in the neck area within 6 months before enrollment.
- Deoxycholic acid injections or cryolipolysis in the submentum area within 6 months before enrollment.
- Neck surgeries and procedures.
- Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments.
- Pregnant, nursing or planning a pregnancy.
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2024
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT05316233
Start Date
May 2 2022
End Date
September 12 2024
Last Update
April 29 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Steve Yoelin MD Medical Associate Inc /ID# 239072
Newport Beach, California, United States, 92663
2
Laser & Skin surgery Medical group, Inc /ID# 241999
Sacramento, California, United States, 95816-5520
3
Cosmetic Laser Dermatology /ID# 239121
San Diego, California, United States, 92121-2119
4
Art of Skin MD /ID# 239071
Solana Beach, California, United States, 92075-2228