Status:
COMPLETED
A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator with a Skincare Regimen
Lead Sponsor:
Galderma R&D
Conditions:
Photodamaged Skin
Volume Deficiency of the Midface
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
To assess skin structural change in midface after treatment with a biostimulator using Line-Field Optical Coherence Tomography
Detailed 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05963204
Start Date
July 7 2023
End Date
March 19 2024
Last Update
October 24 2024
Active Locations (1)
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1
Markowitz Medicals
New York, New York, United States, 10128