Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population

Galderma

Status

Completed

Conditions

Healthy Volunteers

Treatments

Device: Restylane

Device: Perlane

Study type

Interventional

Funder types

Industry

Identifiers

NCT02565784

05DF1315

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.

Enrollment

100 patients

Sex

Female

Ages

25 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects intent to undergo facial filler treatment for either volume loss or contouring
Subjects requiring treatment in two to four of pre-defined areas in the face (upper cheeks, nasolabial folds, temples, nose and chin)
Require 3-5 ml of investigational products to achieve a clinically meaningful improvement in appearance
Facial appearance as Han Chinese
Non-pregnant, non-breast feeding female
Signed informed consent

Exclusion criteria

Previous facial surgery (e.g. rhinoplasty) or permanent implant in the area to be treated.
History of chronic sinusitis or rhinitis (only applicable for subjects injected in the nose).
Subjects who needs to use heavy glasses during the study (only applicable for subjects injected in the nose).
Previous tissue augmenting therapy or contouring with permanent filler or fat injection in the facial area.
Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skinboosters in the facial area within 12 months before treatment.
Previous treatment with non-HA fillers such as CaHA (Calcium Hydroxylapatite) or PLLA (Poly L-Lactic Acid) within 24 months before treatment.
Previous revitalization with neurotoxin in the facial area within six (6) months before treatment.
Previous tissue revitalization treatment with laser or light, mesotherapy, chemical peeling or dermabrasion in the facial area within six (6) months before treatment.
Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).