A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator with a Skincare Regimen

Last updated: October 22, 2024
Sponsor: Galderma R&D
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Sculptra and Alastin Restorative Skin Complex

Sculptra and CeraVe Daily Moisturizing Lotion

Clinical Study ID

NCT05963204
GLI.04.US.SL.023
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To assess skin structural change in midface after treatment with a biostimulator using Line-Field Optical Coherence Tomography

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each sideof the face as assessed via the Galderma Cheek Wrinkles Scale.

  • Subjects with symmetrical, mild-to-severe photodamage at both sides of the midface.

  • Subject who in the opinion of the treating investigator would need 2 biostimulatortreatments for optimal clinical outcomes.

  • Ability of giving consent for participation in the study.

  • Agreement to adhere to the procedures and requirements of the study and to report tothe institute on the day(s) and at the time(s) scheduled for the assessments.

Exclusion

Exclusion Criteria:

  • Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2sides of the cheek.

  • Asymmetrical severity photodamage score between 2 sides of the midface.

  • Subjects with a history of allergy or hypersensitivity to any ingredient of thetreatment products.

  • Previous tissue-augmenting therapy, contouring, or revitalization treatment in theface, except lips.

  • Previous treatment/procedure in the face in the previous 6 months that, in theInvestigator's opinion, would interfere with the study injections and/or studyassessments or exposed the study subject to undue risk by study participation, orplanning to undergo any of these procedures affecting the treatment area at any timeduring the study.

  • Subjects with any medical condition that, in the opinion of the Investigator, wouldmake the subject unsuitable for inclusion.

Study Design

Total Participants: 21
Treatment Group(s): 2
Primary Treatment: Sculptra and Alastin Restorative Skin Complex
Phase:
Study Start date:
July 07, 2023
Estimated Completion Date:
March 19, 2024

Study Description

This is a randomized, double-blinded, split-face, comparative study.

This study is designed to enroll and randomize approximately 20 subjects. All subjects are to have midface volume loss and contour deficiency and facial photodamage.

Eligible subjects are randomized to receive study skincare products for pre-conditioning, 2 weeks before Baseline. All subjects receive biostimulator treatment at the midface by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator.

At the 6-week visit, after all study procedures for the visit are completed, treated subjects received a second biostimulator treatment to achieve optimal aesthetic improvement. At the 12-week and 18-week visits, similar study procedures are performed.

Connect with a study center

  • Markowitz Medicals

    New York, New York 10128
    United States

    Site Not Available

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