Ultherapy Prime for Loose Skin
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Ultherapy Prime to assess its effectiveness in improving the appearance of loose skin, lines, and wrinkles on the lower face and neck. Researchers aim to determine whether delivering the treatment at multiple depths is more effective than at a single depth for lifting, tightening, and smoothing the skin. Individuals with moderate to severe skin looseness in these areas, who have not recently undergone cosmetic procedures, are ideal candidates for this trial. Participants will attend several visits over a year to monitor their progress and provide feedback on the treatment. As an unphased trial, this study allows participants to contribute to innovative research and potentially experience early benefits of the treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using isotretinoin or other oral retinoids, you must have stopped them at least 12 months before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that Ultherapy Prime is safe, whether used at different depths or at a single depth of 1.5 mm. It builds on the safety record of the original Ultherapy. Supported by over 120 scientific articles and used more than 3 million times, this treatment typically causes mild and temporary side effects, such as slight redness or swelling, which usually disappear within a few hours to a few days.
The FDA has approved the Ulthera System, including Ultherapy Prime, for lifting skin and improving lines and wrinkles. This approval indicates that it has been tested to ensure safe and effective use for these purposes. Safety data supports its intended use, and participants in past studies have generally reported high satisfaction, indicating the treatment is well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about Ultherapy Prime for treating loose skin because it offers a non-invasive approach that targets multiple layers of tissue beneath the skin's surface, unlike traditional treatments such as surgical facelifts. The Multi-Depth Ultherapy Prime Treatment uses micro-focused ultrasound energy at varying depths to stimulate collagen production, potentially enhancing skin lifting, tightening, and quality. On the other hand, the Single-Depth Ultherapy Prime Treatment focuses solely on the 1.5 mm depth, exploring whether this targeted delivery can achieve significant skin improvement. This innovative mechanism of action and delivery method sets Ultherapy Prime apart from existing options, providing a promising alternative for those seeking non-surgical skin rejuvenation.
What evidence suggests that this trial's treatments could be effective for improving skin laxity?
Research has shown that Ultherapy Prime, which uses focused ultrasound waves, can improve loose skin and boost collagen production, resulting in tighter and lifted skin. Studies have found that Ultherapy Prime can reach deeper skin layers without harming the surface, making it a safe and effective choice for skin tightening. Strong evidence supports its benefits, with over 50 clinical studies and many scientific papers confirming its effectiveness. In this trial, participants in the multi-depth Ultherapy Prime treatment arm will receive treatment aimed at enhancing lifting and tightening by stimulating collagen at different skin levels. Meanwhile, participants in the single-depth treatment arm will receive Ultherapy Prime at 1.5 mm, which has shown promise in improving skin appearance and is one of the FDA-approved options for the face and neck. Overall, Ultherapy Prime has a high satisfaction rate, with 95% of users satisfied with the results after one year.15678
Who Is on the Research Team?
Jennifer Levine, MD
Principal Investigator
Principal Investigator
Are You a Good Fit for This Trial?
Adults aged 25-65 with moderate to severe skin laxity in the lower face and neck are eligible for this trial. Candidates should be suitable for non-invasive ultrasound treatment. They must avoid certain products, shave if necessary, and refrain from other aesthetic procedures during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening/Treatment
Participants are screened for eligibility to participate in the trial and receive a single Ultherapy Prime treatment session
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1 month, 3 months, 6 months, and 12 months
Long-term Follow-up
Evaluation of whether aesthetic improvement persists at 12 months using GAIS, photography, and patient satisfaction surveys
What Are the Treatments Tested in This Trial?
Interventions
- Ultherapy Prime
Trial Overview
The trial is testing Ultherapy Prime's safety and effectiveness on improving facial lines, wrinkles, and skin tightness over a year. It compares two methods: one using multiple depths of ultrasound energy versus another at just a single depth (1.5 mm).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants in this arm will receive a single full-face and neck Ultherapy Prime treatment delivered exclusively at the 1.5 mm depth, which is one of the FDA-cleared depths for treatment of the lower face and neck. This protocol evaluates whether single-depth energy delivery can achieve meaningful skin improvement compared with multi-layer treatment.
Participants in this arm will receive a single full-face and neck Ultherapy Prime treatment delivered at multiple depths according to the manufacturer's guidelines for MFU-V energy placement. Energy will be applied using the appropriate transducers for each anatomical depth to target multiple layers of tissue beneath the skin surface. The goal is to stimulate collagen production at varying focal points to enhance lifting, tightening, and overall skin quality.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Levine Center for Plastic Surgery
Lead Sponsor
Citations
Before and After - Ultherapy
*Indicated to improve the appearance of skin laxity on the abdomen, anterior arms and posterior arms. Find Out More → ×.
Long-Term Efficacy and Duration of MFU-V at Multiple ...
The primary endpoint evaluates whether treatment with Ultherapy Prime results in a measurable improvement in lifting, tightening, and skin ...
A Systematic Review of the Clinical Efficacy of Micro- ...
MFU treatment can activate deeper tissues without causing injury to the epidermis, which sets it apart from all other skin tightening methods.
Ultherapy Prime for Loose Skin
The goal of this clinical trial is to evaluate the long-term safety and effectiveness of Ultherapy Prime (MFU-V) for improving lines, ...
About - Meet Ultherapy Prime
95% patient satisfaction at year one · The strongest* clinical body of evidence with over 50 clinical studies and more than 120 peer-reviewed papers published ...
Instructions for Use
NOTE: For quality and safety reasons, the Ulthera® System collects data regarding patient treatment and stores it on the device. If a device operator enters ...
FAQs - Ultrasound Treatment, Cost, Side Effects
Ultherapy PRIME® builds on the established safety profile of Ultherapy®, which is scientifically supported by more than 120 publications and over 3 million ...
Ultherapy Near Me Houston TX - Non-Surgical Skin Lifting
Ultherapy has an excellent safety profile when performed by qualified practitioners, with most side effects being mild and temporary. Common ...
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