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NCT Number: NCT07399028

A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging

Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Luxurgery

New York, 10021, United States

Location status: Recruiting

Location contact

Christina Uong

CONTACT

[email protected]

212-508-0000

Sachin Shridarani, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult subjects aged 45-65 years old
  • Females only
  • Subject with moderate-to-severe cheek wrinkles on the GCWS
  • Subject with intent to undergo correction of cheek wrinkles on both sides of the face
  • Subject who in the opinion of the Investigator would need 3 treatments for optimal clinical outcomes
  • Subject willing to be photographed at each visit.
  • Subjects willing to stop using current facial skincare products for the duration of the study.
  • Subject willing to replace the current facial skincare products with the provided facial skincare products, including cleanser, moisturizer and sunscreen, until study completion.
  • Ability to read, understand and give consent for participation in the study.
  • Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments.

Exclusion criteria

  • 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®

Device

Sculptra injection will be performed to the cheeks using 25 G needle size. Injections will be performed subdermally, i.e., in the subcutaneous and supraperiosteal region. A maximum of 18 mL (2 vials) of Sculptra will be administered per treatment session with a maximum of 9 mL (1 vial) per cheek, evenly distributed within the treatment area.

Primary outcomes

  1. Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging

    Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baseline

    Images taken with VISIA imaging system and an imaging system using tomography technology at baseline and post-baseline timepoints will be compared to assess structural changes in cheeks.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Single-center, Open-label Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

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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