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OpenTrials
Completed

NCT Number: NCT05963204

A Study to Evaluate the Effects for Midface Improvement 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

Completed

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Markowitz Medicals

New York, 10128, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sculptra and Alastin Restorative Skin Complex

Combination Product

Biostimulator and cosmetics

Sculptra and CeraVe Daily Moisturizing Lotion

Combination Product

Biostimulator and cosmetics

Primary outcomes

  1. Structural change in midface post-treatment with a biostimulator compared to pre-treatment

    Time frame: 6 weeks and 18 weeks after Baseline

    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.

Secondary outcomes

  1. Improvement in clinical grading score compared to pre-treatment

    Time frame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline

    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.

  2. Subject satisfaction using a self-assessment questionnaire

    Time frame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline

    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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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