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

Completed · Not applicable

Conditions studied: Photodamaged Skin, Volume Deficiency of the Midface

In brief

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

Key facts

Study ID

NCT05963204

Run by

Galderma R&D

People needed

21

Starts

2023-07-07

Expected to finish

2024-03-19

Last updated by the study team

2024-10-24

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of 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 biostimulator treatments 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 to the institute on the day(s) and at the time(s) scheduled for the assessments.

You may not qualify if…

• Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides 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 the treatment products.
• Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
• Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
• Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.

Where it is running

• Markowitz Medicals — New York, New York, United States

Full record on ClinicalTrials.gov

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