BridgeMD
New treatment option for Lax Skin
Official title Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
ClinicalTrials.gov ID: NCT06333067
What this study is testing
- What it's testing
- Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
- 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 35 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Healthy female and male people between the ages 35-80.
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
- Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
You likely can't join if
- 1\. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- 2\. Presence of any active systemic or local infections.
- 3\. Presence of active local skin disease that may alter wound healing.
- 4\. Severe solar elastosis.
- 5\. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.
- 6\. History of chronic drug or alcohol abuse.
See the full eligibility criteria
- Healthy female and male people between the ages 35-80.
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
- Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
- Able to understand and provide written Informed Consent.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
- Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
- Stable weight over the last 12 weeks and throughout the duration of the study.
- 1\. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- 2\. Presence of any active systemic or local infections.
- 3\. Presence of active local skin disease that may alter wound healing.
- 4\. Severe solar elastosis.
- 5\. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.
- 6\. History of chronic drug or alcohol abuse.
- 7\. Excessive subcutaneous fat on the cheeks.
- 8\. Significant scarring in the area to be treated.
- 9\. Severe or cystic facial acne, and/or Accutane use during past 6 months.
- 10\. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
- 11\. Inability to understand the protocol or to provide a signed informed consent.
- 12\. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 6 months; ablative or...
- 13\. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
- 14\. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- La Mesa, California, United States
- Durham, North Carolina, 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 all sexes, 35 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Mesa, California, United States; Durham, North Carolina, 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.