Clinical trial NCT05342753: Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
Official title: A Prospective Clinical Study to Evaluate Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Augmentation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2022-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.


Eligibility criteria: Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent
* Ability to adequately understand the verbal explanations and the written subject information provided in English
* Subjects seeking augmentation therapy for the lips
* Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
* Previous use of any permanent (non-biodegradable) or semipermanent (e.g., calcium hydroxylapatite or poly-L-lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat below the level of the lower orbital rim.
* Previous use of any HA-based or collagen-based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months prior to the baseline visit.
* Previous facial surgery, within 6 months, below the level of the lower orbital rim
* Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
* Participation in any interventional clinical study within 30 days of screening

Primary outcomes:
measure: Proportion of participants assessed as at least 1-point improvement from baseline on MLFS
timeFrame: Week 8
measure: Proportion of participants assessed as at least 1-point improvement from baseline on MLFS
timeFrame: Week 16
measure: Proportion of participants assessed as at least 1-point improvement from baseline on MLFS
timeFrame: Week 24
measure: Proportion of participants assessed as at least 1-point improvement from baseline on MLFS
timeFrame: Week 32
measure: Proportion of participants assessed as at least 1-point improvement from baseline on MLFS
timeFrame: Week 40
measure: Proportion of participants assessed as at least 1-point improvement from baseline on MLFS
timeFrame: Week 48
measure: Change from baseline/last injection on MLFS
timeFrame: Weeks 8, 16, 24, 32, 40 and 48
Secondary outcomes:
measure: Percentage of participants assessed as at least 1-point improvement from baseline on WAS
timeFrame: Weeks 8, 16, 24, 32, 40, and 48
measure: Percentage of participants assessed as at least improved on the GAIS
timeFrame: Weeks 8, 16, 24, 32, 40, and 48
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Galderma Research Site
state: California
city: Vista
country: United States
facility: Galderma Research Site
state: California
city: Ardmore
country: United States
facility: Galderma Research Site
state: Pennsylvania
city: Taipei
country: Taiwan
facility: Galderma Research Site
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References: