To assess skin structural change in midface after treatment with a biostimulator using Line-Field Optical Coherence Tomography
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
Biostimulator and cosmetics
Biostimulator and cosmetics
Markowitz Medicals
New York, New York, United States
Structural change in midface post-treatment with a biostimulator compared to pre-treatment
Percent change in collagen fiber density using Line-Field Confocal Optical Coherence Tomography at defined timepoints compared to baseline. Collagen density is defined as a number of fibers and is measured on each side of the midface.
Time frame: 6 weeks and 18 weeks after Baseline
Improvement in clinical grading score compared to pre-treatment
Percent change in skin parameters includes photodamage, roughness, radiance at defined timepoints compared to re-treatment. Each parameter is assessed by the Investigator on each side of the face using a 10-point Modified Griffiths' scale where 0 = none and 9 = severe.
Time frame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
Subject satisfaction using a self-assessment questionnaire
Survey where subjects are asked about their satisfaction with treatment outcome on each half of their face. A 5-point subject satisfaction questionnaire with the following responses: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree.
Time frame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
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