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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biostimulator and Facial Moisturizer A | Active Comparator | Biostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6. Facial Moisturizer A is a cream with active TriHex technology. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study. |
|
| Biostimulator and Facial Moisturizer B | Active Comparator | Biostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6. Facial Moisturizer B is a neutral, oil-free moisturizing lotion. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sculptra and Alastin Restorative Skin Complex | Combination Product | Biostimulator and cosmetics |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks and 18 weeks after Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orit Markowitz, MD | Markowitz Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markowitz Medicals | New York | New York | 10128 | United States |
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| Sculptra and CeraVe Daily Moisturizing Lotion | Combination Product | Biostimulator and cosmetics |
|
| 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. | Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline |
| ID | Term |
|---|---|
| C482305 | New-Fill |
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