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

NCT ID: NCT05963204

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2024-03-19

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 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.

Conditions

Photodamaged Skin; Volume Deficiency of the Midface

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sculptra and Alastin Restorative Skin Complex

Intervention Type: COMBINATION_PRODUCT

Biostimulator and cosmetics

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.

Group Type: ACTIVE_COMPARATOR

Sculptra and CeraVe Daily Moisturizing Lotion

Intervention Type: COMBINATION_PRODUCT

Biostimulator and cosmetics

Interventions

Sculptra and Alastin Restorative Skin Complex

Biostimulator and cosmetics

Intervention Type: COMBINATION_PRODUCT

Sculptra and CeraVe Daily Moisturizing Lotion

Biostimulator and cosmetics

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Orit Markowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Markowitz Medical

Locations

Markowitz Medicals

New York, New York, United States

Countries

United States

Other Identifiers

GLI.04.US.SL.023

Identifier Type: -

Identifier Source: org_study_id