BridgeMD
Tests treatment safety and results for Laxity; Skin
Official title Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm
ClinicalTrials.gov ID: NCT07224308
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the long-term safety and effectiveness of Ultherapy Prime (MFU-V) for improving lines, wrinkles, laxity, and crepiness of the lower face, submentum, and neck. The study will enroll adult male and female subjects aged 25-65 with moderate to severe lower-face and neck skin laxity who are appropriate candidates for non-invasive ultrasound treatment.
- Time commitment: about 12 months
- 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 25 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Male or female people between 25 and 65 years of age at the time of screening.
- Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with...
- Skin condition not advanced enough to require surgical correction.
- Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
- Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
You likely can't join if
- Male or female people between 25 and 65 years of age at the time of screening.
- Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with...
- Skin condition not advanced enough to require surgical correction.
- Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
- Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
- Sufficient English language proficiency to understand study instructions and complete questionnaires.
See the full eligibility criteria
Who can join
- Male or female people between 25 and 65 years of age at the time of screening.
- Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with non-invasive MFU-V treatment.
- Skin condition not advanced enough to require surgical correction.
- Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
- Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
- Sufficient English language proficiency to understand study instructions and complete questionnaires.
- For participants of childbearing potential: negative urine pregnancy test on the day of treatment and willingness to use adequate contraception during the study.
- Ability to provide written informed consent.
What rules you out
- Male or female people between 25 and 65 years of age at the time of screening.
- Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with non-invasive MFU-V treatment.
- Skin condition not advanced enough to require surgical correction.
- Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
- Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
- Sufficient English language proficiency to understand study instructions and complete questionnaires.
- For participants of childbearing potential: negative urine pregnancy test on the day of treatment and willingness to use adequate contraception during the study.
- Ability to provide written informed consent.
- Exclusion Criteria:
- Active systemic or local skin disease (e.g., eczema, psoriasis, dermatitis, infection) that may affect wound healing or the evaluation of results.
- Scarring, tattoos, or significant pigmentary alterations in the planned treatment areas.
- Metallic implants or other implanted electronic devices (e.g., pacemakers) in or near the treatment area.
- Open wounds, lesions, active herpes simplex, or active cystic/severe inflammatory acne in the treatment area.
- Use of isotretinoin or other oral retinoids within the past 12 months or planned use during the study.
- Microdermabrasion or medical-grade glycolic acid treatments to the treatment area within 2 weeks prior to participation.
- Deep dermal scarring, thick sebaceous skin, or severe solar elastosis in the treatment area that may interfere with treatment or evaluation.
- Intention to gain or lose ≥ 2 BMI units during the 12-month study period.
- Known allergy or hypersensitivity to any component of the device or ultrasound coupling gel.
- History of chronic drug or alcohol abuse or opioid dependence.
- Recent aesthetic procedures to the lower face, submentum, or neck that may confound study outcomes (e.g., fillers, neurotoxins, lasers, threads, RF, ultrasound) within the protocol-specified washout period.
- Participation in another clinical study involving an investigational device or drug within 30 days prior to treatment.
- Pregnancy, breastfeeding, or plans to become pregnant during the study.
- Any condition that, in the opinion of the investigator, would increase risk or interfere with study participation or data interpretation.
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 65 years. Healthy volunteers may be eligible. 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.
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.