Clinical trial NCT05316233: 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
Official title: Multicenter, Evaluator-blinded, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neck Lines
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 159
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 skin. The neck is a frequently mentioned area by patients complaining about its crepey texture and deep lines. VOLITE XC is a crosslinked HA gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of treating fine lines and improving skin quality. The purpose of this study is to assess adverse events and effectiveness of VOLITE XC in adults seeking improvement in neck appearance.

VOLITE XC is an investigational product being developed for the improvement of horizontal neck lines. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 212 adult participants with transverse neck lines will be enrolled in the study at approximately 20 sites.

Participants in the treatment group will receive VOLITE XC at Day 1 and followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period. The control group received no treatment and will be followed for up to 6 months after randomization. Participants can then opt to receive VOLITE XC and followed for 6 Months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Achieving "Responder" status based on Evaluating Investigator's (EI) live assessment of transverse neck lines using the Allergan Transverse Neck Lines Scale (ATNLS)
timeFrame: Month 1
measure: Number of Participants with Adverse Events
timeFrame: Up to 14 Months
Secondary outcomes:
measure: Percentage of Participants Achieving "Responder" Status for EI's Assessment of global aesthetic improvement on the neck using the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Month 1
measure: Percentage of Participants Achieving "Responder" Status for Participant's Assessment of global aesthetic improvement on the Neck using GAIS
timeFrame: Month 1
measure: Change from baseline to Month 1 in the Rasch-transformed scores on FACE-Q Appraisal of the Neck questionnaire
timeFrame: Baseline to Month 1
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Steve Yoelin MD Medical Associate Inc /ID# 239072
state: California
city: Sacramento
country: United States
facility: Laser & Skin surgery Medical group, Inc /ID# 241999
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology /ID# 239121
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD /ID# 239071
state: California
city: Washington
country: United States
facility: Center for Dermatology and Dermatologic Surgery /ID# 239137
state: District of Columbia
city: Coral Gables
country: United States
facility: Hevia Cosmetic Dermatology /ID# 239118
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute LLC /ID# 239109
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC /ID# 239070
state: Florida
city: New Orleans
country: United States
facility: Delricht Research /ID# 242001
state: Louisiana
city: North Bethesda
country: United States
facility: Rkmd, Llc /Id# 239075
state: Maryland
city: Montclair
country: United States
facility: image Dermatology, P.C. /ID# 239136
state: New Jersey
city: New York
country: United States
facility: Skin And Aesthetics Surgery Of Manhattan /ID# 243607
state: New York
city: West Islip
country: United States
facility: Mariwalla Dermatology /ID# 239102
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions /ID# 239074
state: North Carolina
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 239133
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: