Photo-aged Skin, Skin Laxity, Volume Deficiency in the Mid-Face
Conditions
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.
Interventions
DEVICESculptra®
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
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging | 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. |
Countries
United States
Outcome results
None listed