NCT02565784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 3, 2019

Completed
Last Updated

August 26, 2022

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 23, 2015

Results QC Date

September 10, 2019

Last Update Submit

August 24, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator

    6 and 12 Months after first and second treatment, respectively

  • Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator

    6 and 12 Months after first and second treatment, respectively

Study Arms (1)

Intradermal injection

EXPERIMENTAL

Restylane and/or Perlane

Device: RestylaneDevice: Perlane

Interventions

RestylaneDEVICE

Facial tissue augmentation

Intradermal injection
PerlaneDEVICE

Facial tissue augmentation

Intradermal injection

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Galderma Research Site

Kaohsiung City, Taiwan

Location

Galderma Research Site

Taipei, Taiwan

Location

Results Point of Contact

Title
Clinical Project Manager
Organization
Q-Med AB
reception.seupp@galderma.com
+46184749000

Study Officials

  • Q-Med AB

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

October 1, 2015

Study Start

December 1, 2015

Primary Completion

December 29, 2016

Study Completion

September 28, 2018

Last Updated

August 26, 2022

Results First Posted

October 3, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)