A Restylane Treatment Algorithm Approach for Participants With Appearance of Insufficient Bone Structure in the Lower Face Alone or in Combination With Facial Soft Tissue Deficiencies

Last updated: January 29, 2025
Sponsor: Galderma R&D
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Restylane Shaype

Restylane Lyft lidocaine

Restylane Defyne

Clinical Study ID

NCT06428214
05DF2307
  • Ages > 18
  • All Genders

Study Summary

The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is willing to comply with the requirements of the study including beingphotographed, following post-treatment care instructions, attending all study visitsand providing a signed written informed consent.

  • Males or non-pregnant, non-breastfeeding females, over the age of 18.

  • Intent to receive treatment for temporary augmentation in the chin region.

Exclusion

Exclusion Criteria:

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA)gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaineor other amide-type anesthetics

  • Previous or present multiple allergies or severe allergies, such as manifested byanaphylaxis or angioedema, or family history of these conditions.

  • Previous facial surgery (including facial aesthetic surgery and liposuction), belowthe level of the horizontal line from the lower orbital rim.

  • Any previous aesthetic procedures or implants.

  • Use of concomitant medication that have the potential to prolong bleeding times suchas anticoagulants or inhibitors of platelet aggregation.

  • Participation in any other interventional clinical study within 30 days (about 4 anda half weeks) before baseline.

  • Women who are pregnant or breast feeding, or women of childbearing potential who arenot practicing adequate contraception or planning to become pregnant during thestudy period.

Study Design

Total Participants: 45
Treatment Group(s): 3
Primary Treatment: Restylane Shaype
Phase:
Study Start date:
May 13, 2024
Estimated Completion Date:
September 24, 2024

Connect with a study center

  • Galderma Investigational Site # 8754

    Vancouver, British Columbia V6H 4E1
    Canada

    Site Not Available

  • Galderma Investigational Site 8379

    Burlington, Ontario L7N3N2
    Canada

    Site Not Available

  • Galderma Investigational Site 8690

    Westmount, Quebec H3Z 1C3
    Canada

    Site Not Available

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