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OpenTrials
Completed

NCT Number: NCT02565784

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

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.

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Key information

Conditions

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Research Site, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Restylane

Device

Facial tissue augmentation

Perlane

Device

Facial tissue augmentation

Primary outcomes

  1. Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant

    Time frame: 6 Months

    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.

Secondary outcomes

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

    Time frame: 6 and 12 Months after first and second treatment, respectively

    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.

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

    Time frame: 6 and 12 Months after first and second treatment, respectively

    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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Oct 1, 2015
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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