NCT07399028

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Oct 2025Sep 2026

Study Start

First participant enrolled

October 21, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 13, 2026

Last Update Submit

February 2, 2026

Conditions

Volume Deficiency in the Mid-FaceSkin LaxityPhoto-aged Skin

Outcome Measures

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

    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.

    4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baseline

Study Arms (1)

Treatment Group

EXPERIMENTAL

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.

Device: Sculptra®

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.

Treatment Group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luxurgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

February 10, 2026

Study Start

October 21, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 10, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)