Clinical trial NCT05741034: A Study to Assess Adverse Events and Effectiveness of Injected JUVÉDERM® VOLITE™ Gel Filler for Change in Neck Lines in Adult Chinese Participants
Official title: Multicenter, Evaluator-blinded, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLITE™ for Correction of Neck Lines in Chinese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neck Lines
Keywords: Neck Lines
Skin Wrinkling
Juvederm VOLITE
VOLITE
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 159
Sex: ALL
Minimum age (years): 18
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 participants complaining about its crepey texture and deep lines. JUVÉDERM® VOLITE™ is a crosslinked Hyaluronic Acid (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 in Chinese adults seeking correction of transverse neck lines.

VOLITE is an investigational product being developed for correction of transverse 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 159 adult participants with transverse neck lines will be enrolled in the study at approximately 8 sites in China.

Participants in the treatment group will receive the initial injection of VOLITE at Visit 1 and followed for up to 13 months. Participants may have the opportunity to receive optional touch-up treatment of VOLITE during the follow-up duration period. Participants in the control group will receive no treatment but will have the opportunity to receive VOLITE treatment after 2 months. Participants in the control group will be followed for up to 10 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 (TI) judgment, including no known active pandemic infection.
* Participants seeking improvement of transverse neck lines and hydration in neck area.
* Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment.
* The participant is able to achieve at least a 1-point improvement in Allergan Transverse Neck Lines Scale (ATNLS) score with the allowed injection volume in the judgment of TI.

Exclusion Criteria:

* Neck deformity or significant skin laxity with severe redundant folds.
* History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA (hyaluronic acid) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
* Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease).
* Current cutaneous inflammatory or infectious processes (e.g., acne, herpes, dermatitis), abscess, an unhealed wound, or a cancerous or precancerous lesion on skin of the neck.
* History of thyroid cancer, thyroid-related diseases, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area.
* Tendency to develop hypertrophic scarring.
* Has ever received permanent soft tissue fillers (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene), calcium hydroxyapatite filler, or autologous fat in the neck area.
* Has undergone neck surgery.
* Semi-permanent soft tissue fillers (e.g., poly-L-lactic acid, polycaprolactone) in the neck area within 2 years before enrollment.
* Botulinum toxin in the neck area within 6 months before enrollment.
* Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments.

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 2
measure: Number of Participants with Adverse Events
timeFrame: Up to 13 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 2
measure: Percentage of Participants Achieving "Responder" Status for Participant's Assessment of global aesthetic improvement on the Neck using GAIS
timeFrame: Month 2
measure: Change from baseline to Month 2 on FACE-Q Appraisal of Neck questionnaire overall score
timeFrame: Baseline to Month 2
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital /ID# 243984
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital /ID# 243982
state: Beijing
city: Xicheng District
country: China
facility: Peking University First Hospital /ID# 243980
state: Beijing
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-Sen University /ID# 243987
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 243981
state: Hubei
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 243986
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital /ID# 245875
state: Jiangsu
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 244044
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 244107
state: Tianjin
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: