Clinical trial NCT03519204: Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults
Official title: A Randomized, Multicenter, No-treatment Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Enhancement
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years of age or older with an overall baseline Lip Fullness Scale (LFS) score of minimal, mild or moderate on the 5-point LFS scale.
* Has the ability to follow study instructions and is likely to complete all required visits

Exclusion Criteria:

* Has had any facial procedures or trauma that may interfere with the study procedures and results
* Is on anti-coagulation therapy or other contraindicated treatments
* Has current cutaneous inflammatory or infectious processes or lesions in the mouth area

Primary outcomes:
measure: Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)
timeFrame: Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)
Secondary outcomes:
measure: Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS
timeFrame: Baseline to Month 3 Post Treatment
measure: Change From Baseline in Overall Lip Volume
timeFrame: Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)
measure: Percentage Change From Baseline in Lip Surface Area
timeFrame: Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)
measure: Procedural Pain Score
timeFrame: Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine
measure: Number of Participants With Injection Site Responses (ISRs)
timeFrame: Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline to Month 12 Post Treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: General Hospital of Southern Theatre Command
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Allergan
name: Smita Chawla
role: STUDY_DIRECTOR
References:
citation: Li D, Gao Z, Sun J, Li Q, Jiang P, Zhang L, Chawla S. Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults. Clin Cosmet Investig Dermatol. 2022 Nov 10;15:2427-2436. doi: 10.2147/CCID.S382194. eCollection 2022.