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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Photodamaged Skin; Volume Deficiency of the Midface
• Intervention / Treatment: Combination product: Sculptra and Alastin Restorative Skin Complex; Combination product: Sculptra and CeraVe Daily Moisturizing Lotion

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 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
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Markowitz Medicals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biostimulator and Facial Moisturizer A; 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; Biostimulator and cosmetics
Active Comparator: Biostimulator and Facial Moisturizer B; 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; Biostimulator and cosmetics

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Orit Markowitz, MD, Markowitz Medical

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Actual): March 19, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: GLI.04.US.SL.023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes