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

NCT07399028 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-02-10

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399028 on ClinicalTrials.gov