Clinical trial NCT02565784: Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator
timeFrame: 6 and 12 Months after first and second treatment, respectively
measure: Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator
timeFrame: 6 and 12 Months after first and second treatment, respectively
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Galderma Research Site
city: Taipei City
country: Taiwan
facility: Galderma Research Site
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References: