CompletedNot Applicable

Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening

United States22 participantsStarted 2006-10

Plain-language summary

The purpose of this research study is to evaluate effectiveness of a non-ablative (does not remove skin) treatment for cellulite (dimpled fat) in conjunction with skin tightening using the Candela GentleYAG laser.

Who can participate

Age range

40 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

. Individuals, male or female, greater than 40 years of age.
. Moderate skin laxity in the arms, legs, abdomen, or neck.
. Subject is not overweight. Body Mass Index (B.M.I.) is ≤ 27.
. Subject has Fitzpatrick skin phototype I-IV.
. Subject is willing to participate in study and adhere to follow-up schedule.
. Subject is able to read and comprehend English.
. Subject has completed Informed Consent Form.

Exclusion criteria

. Subjects that have had liposuction or other surgical procedures (including mesotherapy) to remove fat in the treatment area during the past year.
. Subject is overweight (BMI \> 27).
. Subject has known photosensitivity or history of ingesting medications known to induce photosensitivity in the previous 3 months.
. Subject has a personal or family history of keloid formation or scarring.

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 Mild to Moderate Reduction in Cellulite.

Timeframe: 6 month follow up

Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.

Timeframe: 6 month follow up

Trial details

NCT IDNCT00585715

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12

Results submitted2011-06-17

View on ClinicalTrials.gov More Localized Lipodystrophy trials