Clinical trial NCT05963204: A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator with a Skincare Regimen
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photodamaged Skin
Volume Deficiency of the Midface
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 21
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Structural change in midface post-treatment with a biostimulator compared to pre-treatment
timeFrame: 6 weeks and 18 weeks after Baseline
Secondary outcomes:
measure: Improvement in clinical grading score compared to pre-treatment
timeFrame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
measure: Subject satisfaction using a self-assessment questionnaire
timeFrame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Markowitz Medicals
state: New York
Study officials:
affiliation: Markowitz Medical
name: Orit Markowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: