This trial is active, not recruiting.

Condition healthy volunteers
Treatments restylane, perlane
Phase phase 4
Sponsor Q-Med AB
Start date December 2015
End date December 2016
Trial size 100 participants
Trial identifier NCT02565784, 05DF1315


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Restylane and/or Perlane
Facial tissue augmentation
Facial tissue augmentation

Primary Outcomes

"Global facial aesthetic appearance" (judged by subject)
time frame: 6 months

Secondary Outcomes

Nasolabial fold severity (Merz aesthetic scale)
time frame: 0-24 months
Upper cheek fullness (Merz aesthetic scale)
time frame: 0-24 months
Safety by assessment of Adverse Events throughout the study
time frame: 0-24 months

Eligibility Criteria

Female participants from 25 years up to 50 years old.

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).

Additional Information

Official title An Open, Evaluator-blinded, Non-comparative, Multi-center Study to Assess the Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Q-Med AB.