CompletedNot Applicable

CONFORM: Rotational Fractional Resection for Submental Contouring

United States68 participantsStarted 2018-01-08

Plain-language summary

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy male or female, at least 30 years old * Moderate submental (neck) fat * Mild to moderate submental (neck) skin laxity (loose skin) * Willing and able to provide informed consent * Willing and able to comply with all protocol requirements * Willing to limit direct sun exposure and use sunscreen for duration of the study * Agree to maintain weight for duration of the study * Willing to have photographs taken that could identify the participant Exclusion Criteria: * Previous intervention to treat submental fat or skin laxity * Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure * Sensitivity to local anesthesia * Severe acne, cystic acne or acne scars on neck * Trauma of chin or neck area * Skin infection or rash on neck * Psoriasis, eczema, rosacea, or vitiligo * History of scarring * History or current symptoms of dysphagia * Chronic or persistent coughing * Body mass index (BMI) \> 30 * Clinically significant bleeding disorder * Anemia, kidney disease, or liver disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2

Timeframe: Baseline and 90 days post treatment

Trial details

NCT IDNCT03407313

SponsorRecros Medica, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-28

Results submitted2020-09-22

View on ClinicalTrials.gov More Skin Laxity trials

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.