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

Part of paid clinical trials in New York, New York.

Sponsor
Galderma R&D
Study ID
NCT07399028
Status
Recruiting
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Conditions

  • Photo-aged Skin
  • Skin Laxity
  • Volume Deficiency in the Mid-Face

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Oct 21, 2025
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
LuxurgeryNew YorkNew York10021
Christina Uong
[email protected]
212-508-0000
Sachin Shridarani, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Luxurgery· New York, NY

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