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New treatment option for Volume Deficiency in the Mid-Face
Official title A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
ClinicalTrials.gov ID: NCT07399028
What this study is testing
- What it's testing
- Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only
You may be able to join if
- Adult people 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
You likely can't join if
- people 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...
- people with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.
See the full eligibility criteria
- Adult people 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.
- people 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.
- people 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...
- people with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.