Recruiting

Sculptra

Sponsor:

Galderma R&D

Code:

NCT07399028

Conditions

Volume Deficiency in the Mid-Face

Skin Laxity

Photo-aged Skin

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Not accepted

Interventions

Sculptra®

Study Details

Brief summary:

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

Conditions

Volume Deficiency in the Mid-Face

Skin Laxity

Photo-aged Skin

Study ID

NCT07399028

Start date

Oct 21, 2025

Status verified date

Jan, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Subjects will be treated for correction of fine lines and wrinkles in the cheek area with Sculptra. Subjects will receive 3 treatments with Sculptra, four weeks apart.

Interventions

Sculptra®

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 outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Luxurgery

Recruiting

New York, New York, United States, 10021

Contacts

Christina Uong

212-508-0000cku@luxurgery.com

Principal Investigator:

Sachin Shridarani, MD

More Information

Sponsor

Galderma R&D

Last update posted

Feb 10, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Galderma R&D on 2026-02-10.