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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565784
• Other study ID #: 05DF1315
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: September 28, 2018

Study information

• Verified date: September 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 28, 2018
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Restylane
Facial tissue augmentation
• Perlane
Facial tissue augmentation

Locations

Country	Name	City	State
Taiwan	Galderma Research Site	Kaohsiung
Taiwan	Galderma Research Site	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant	Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment.; The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse.; A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.	6 Months
Secondary	Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator	The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is "No folds" and 4 is "Very severe folds".; A participant is considered improved if she scores at least one grade improvement from baseline.	6 and 12 Months after first and second treatment, respectively
Secondary	Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator	The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is "Full upper cheek" and 4 is "Very severely sunken upper cheek".; A participant is assessed as improved if she scores at least one grade improvement from baseline.	6 and 12 Months after first and second treatment, respectively