BridgeMD
New treatment option for Cheek Wrinkles
Official title A Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages
ClinicalTrials.gov ID: NCT07342400
What this study is testing
- What it's testing
- To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, women only
You may be able to join if
- people diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
- Subject with intent to undergo correction of cheek augmentation or contour deficiencies
- people willing to have a 3-mm punch biopsy on each preauricular side
- people willing to maintain the current lifestyle, daily routine (e.g., diet, exercise, sleep, etc.), and a stable Body Mass Index (BMI, ± 5 kg/m2)...
- Ability of giving consent for participation in the study.
You likely can't join if
- people with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
- 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
- people diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
- Subject with intent to undergo correction of cheek augmentation or contour deficiencies
- people willing to have a 3-mm punch biopsy on each preauricular side
- people willing to maintain the current lifestyle, daily routine (e.g., diet, exercise, sleep, etc.), and a stable Body Mass Index (BMI, ± 5 kg/m2) throughout the study
- Ability of giving consent for participation in the study.
- Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.
- people with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
- 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
- Miami, Florida, United States
- 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, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.