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

Photodamaged Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05963204
• Other study ID #: GLI.04.US.SL.023
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: August 31, 2024
• Est. primary completion date: March 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Photodamaged Skin
• Volume Deficiency of the Midface

Intervention

Combination Product:
• Sculptra and Alastin Restorative Skin Complex
Biostimulator and cosmetics
• Sculptra and CeraVe Daily Moisturizing Lotion
Biostimulator and cosmetics

Locations

Country	Name	City	State
United States	Markowitz Medicals	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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