Ultherapy Prime for Loose Skin

Overseen By Jennifer M Levine, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Levine Center for Plastic Surgery

Must not be taking: Oral retinoids

Disqualifiers: Active skin disease, Metallic implants, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

20 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 5 6 7 8}

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

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

Exclusion Criteria

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

Intention to gain or lose ≥ 2 BMI units during the 12-month study period

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

1 day

1 visit (in-person)

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

12 months

4 visits (in-person)

Long-term Follow-up

Evaluation of whether aesthetic improvement persists at 12 months using GAIS, photography, and patient satisfaction surveys

12 months

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?

Group I: Single-Depth Ultherapy Prime Treatment (1.5 mm) Experimental Treatment 1 Intervention

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.

Group II: Multi-Depth Ultherapy Prime Treatment Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

The Levine Center for Plastic Surgery

Lead Sponsor

Citations

1. ultherapy.com ultherapy.com/physicians/results

Before and After - Ultherapy *Indicated to improve the appearance of skin laxity on the abdomen, anterior arms and posterior arms. Find Out More → ×.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07224308

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8722640/

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.

4. withpower.com withpower.com/trial/phase-cutis-laxa-9-2025-29a9a

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, ...

5. ultherapy.com ultherapy.com/physicians-the-gold-standard

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 ...

6. ultherapy.com ultherapy.com/app/uploads/2021/10/1015107IFU-Rev-A-US-Instructions-for-Use.pdf

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 ...

7. ultherapy.com ultherapy.com/frequently-asked-questions

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 ...

8. dermlasersurgery.com dermlasersurgery.com/procedures/ultherapy/

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 ...