Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects

Galderma

Status

Active, not recruiting

Conditions

Lip Augmentation

Treatments

Device: Restylane Kysse

Study type

Interventional

Funder types

Industry

Identifiers

05DF2007

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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