A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorGalderma R&D
About this trial
Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Sculptra®
DeviceSculptra 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 groups
25 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baselineSponsors and contacts
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Source ClinicalTrials.gov