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

NCT05963204 | Completed FDA Device

• 1 other identifier: GLI.04.US.SL.023
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Photodamaged Skin; Volume Deficiency of the Midface

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improvement in clinical grading score compared to pre-treatment

  Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline

• Subject satisfaction using a self-assessment questionnaire

  Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline

Study Arms (2)

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.

Combination Product: Sculptra and Alastin Restorative Skin Complex

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.

Combination Product: Sculptra and CeraVe Daily Moisturizing Lotion

Interventions

Sculptra and Alastin Restorative Skin Complex COMBINATION_PRODUCT

Biostimulator and cosmetics

Biostimulator and Facial Moisturizer A

Sculptra and CeraVe Daily Moisturizing Lotion COMBINATION_PRODUCT

Biostimulator and cosmetics

Biostimulator and Facial Moisturizer B

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Markowitz Medicals

New York, New York, 10128, United States

Location

MeSH Terms

Interventions

New-Fill

Study Officials

• Orit Markowitz, MD

  Markowitz Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 27, 2023
• Study Start: July 7, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)