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

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

Detailed Description
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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.

Official Title
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A Randomized, Double-blinded, Split-face, Comparative Study to Evaluate the Synergistic Effects for Improving the Aging Midface When Pairing a Biostimulator With a Skincare Regimen

Conditions
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Photodamaged Skin, Volume Deficiency of the Midface

Intervention / Treatment
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* Combination Product: Sculptra and Alastin Restorative Skin Complex
* Combination Product: Sculptra and CeraVe Daily Moisturizing Lotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biostimulator and Facial Moisturizer A<br>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. | Combination Product: Sculptra and Alastin Restorative Skin Complex<br>* Biostimulator and cosmetics<br>|
| Active Comparator: Biostimulator and Facial Moisturizer B<br>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. | Combination Product: Sculptra and CeraVe Daily Moisturizing Lotion<br>* Biostimulator and cosmetics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |