Clinical trial NCT05454033: A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants in China With Fine Lines Around the Mouth
Official title: Multicenter, Evaluator-blind, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLITE™ for Correction of Perioral Lines in Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perioral Lines
Keywords: Dermal
Dermatology
Aesthetics
Skin Care
Juvederm
Volite
Perioral
Fine Lines
Wrinkles
Frown Lines
Laugh Lines
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-07-12
Enrollment: 198
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: 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 injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in correcting perioral lines (around the mouth).

VOLITE is an investigational device being developed for the correction of perioral lines. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of lines, hydration, and skin smoothness in perioral area will be enrolled. Around 198 participants will be enrolled in the study at approximately 12 sites in China.

Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend monthly 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:

* Has moderate or severe perioral lines (Perioral Lines at Rest Severity Scale \[POLSS\] Grades 2 or 3) as assessed by the Evaluating Investigator (EI).
* Participants seeking improvement of lines, hydration, and skin smoothness in perioral area.
* Is able to achieve a 1-point improvement in POLSS score in the judgment of Treating Investigator (TI).
* Participant must be in good health as determined by medical history, vital signs, and TI's judgment, including no known active pandemic infection.

Exclusion Criteria:

* Has a history of anaphylaxis, atopy, or allergy to lidocaine, hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
* Has current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, an unhealed wound, angioneurotic edema, cheilitis, or a cancerous or precancerous lesion in the perioral area that could interfere with effectiveness assessments.
* Has a tendency to develop hypertrophic scarring.
* Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
* Has a history of anaphylactic shock.
* Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease) other than Hashimoto's thyroiditis.
* Has porphyria.
* Has a history of skin cancer.
* Has ever received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) below the subnasale.
* Has ever undergone fat injections or calcium hydroxyapatite below the subnasale.
* Has undergone volume augmentation with semi-permanent soft tissue fillers (e.g., poly-L-lactic acid) within 24 months or temporary soft tissue fillers within 12 months below the subnasale.
* Has undergone treatment with botulinum toxins below the subnasale within 6 months of study entry or is planning to undergo such treatment during the study.
* Has received cosmetic resurfacing below the subnasale within 6 months before enrollment (examples include laser, radiofrequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures) or is planning to undergo such treatment during the study.
* Has received mesotherapy or cosmetic treatments below the subnasale within 3 months before enrollment (e.g., photomodulation, intense pulsed light) or is planning to undergo such treatment during the study.
* Has undergone oral surgery (e.g., tooth extraction, aesthetic restoration of front teeth, or implantation in anterior region) within 30 days before enrollment or is planning to undergo any of these procedures during the study.
* Is undergoing orthodontia before enrollment or is planning to undergo it during the study.
* Has changes in use of over-the-counter or prescription oral anti-wrinkle products or topical products below the subnasale within 30 days before enrollment (participants are not eligible for this study if they have begun using any new over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study).
* Is on a regimen of anti-coagulation therapy (e.g., warfarin, clopidogrel).
* Is on an ongoing regimen of medications (e.g., aspirin, ibuprofen) or other substances (e.g., herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection (study device injection may be delayed as necessary to accommodate this 10-day washout period).
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* Has tattoos, piercings, or scars that would interfere with visual assessment of the perioral lines.
* At TI's discretion, based on participant's safety and/or study integrity, the participant has a condition or is in a situation that, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study, such as clinically significant abnormal lab testing results as judged by TI.
* Directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, or other study staff member; employee of the sponsor; first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or enrolled in the study at another clinical site.

Primary outcomes:
measure: The percentage of participants who achieved at least 1-point improvement from baseline on the Perioral Lines Severity Scale (POLSS)
timeFrame: Up to Month 2
Secondary outcomes:
measure: The percentage of participants assessed as "improved" or "much improved" on the Global Aesthetic Improvement Scale (GAIS) by the EI
timeFrame: Up to Month 2
measure: The percentage of participants assessed as "improved" or "much improved" on the Global Aesthetic Improvement Scale (GAIS) by the participant
timeFrame: Up to Month 2
measure: The change from baseline on the FACE-Q Appraisal of Lines: Lips questionnaire
timeFrame: Up to Month 2
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital /ID# 252139
state: Beijing
city: Beijing
country: China
facility: Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 231394
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital /ID# 231393
state: Beijing
city: Xicheng District
country: China
facility: Peking University First Hospital /ID# 231392
state: Beijing
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-Sen University /ID# 231398
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231396
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 231937
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 244045
state: Jiangsu
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 231395
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 231740
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital /ID# 244111
state: Zhejiang
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: