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Energy-Based Devices for Skin Conditions

N/A

Recruiting

Led By Sean Doherty

Research Sponsored by Cynosure, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to undergo at least 1 treatment with the study device(s)

Understands and accepts the obligation and is logistically able to be present for all visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up procedure (during device treatment)]

Awards & highlights

Study Summary

This trial tests devices that use energy to treat skin issues, to see if they're safe & effective.

Who is the study for?

This trial is for healthy adults aged 22 or older who are willing to undergo at least one skin treatment with the study devices and can commit to all study visits without undergoing other procedures in the area during the trial. Pregnant women, recent Accutane users, those with certain medical implants, steroid use, healing issues, infections, light-triggered seizure disorders or allergies to adhesives cannot participate.Check my eligibility

What is being tested?

The study tests safety and performance of various energy-based devices like combined energy devices, radiofrequency microneedling device, radiofrequency device and intense pulsed light for treating unwanted skin conditions.See study design

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, redness or swelling. There's also a risk of burns from heat-generating devices and possible allergic reactions to topical anesthetics used during treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to try at least one treatment with the study device.

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I can attend all required appointments.

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I am 22 years old or older and healthy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ procedure (during device treatment)]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~procedure (during device treatment)]

This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure (during device treatment)] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum pain reported during treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: RF OnlyExperimental Treatment1 Intervention

Group C will be treated with an RF device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF device that is cleared for use by the FDA.

Group II: RF Microneedling OnlyExperimental Treatment1 Intervention

Group B will be treated with a radiofrequency (RF) microneedling device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF microneedling device that is cleared for use by the FDA.

Group III: IPL onlyExperimental Treatment1 Intervention

Group A will be treated with an intense pulsed light (IPL) device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar IPL device that is cleared for use by the FDA.

Group IV: CombinationExperimental Treatment4 Interventions

Group D will receive combination treatments and will be treated with 2 or more of the study devices.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiofrequency device

2009

N/A

~30

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cynosure, Inc.Lead Sponsor

51 Previous Clinical Trials

1,186 Total Patients Enrolled

Sean DohertyPrincipal InvestigatorCynosure, LLC

4 Previous Clinical Trials

199 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research still require participants for enrollment?

"Indeed, the clinical trial is actively searching for participants. This research project was first publicized on September 28th of 2023 and has since been edited as recently as October 26th of that same year."

Answered by AI

How many volunteers will be admitted to this experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study initiated recruitment on September 28th 2023 and has been actively seeking participants since then. A total of 50 patients need to be enrolled across one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Study to Evaluate Different Energy-based Devices for Aesthetic Treatments.

2023. "Clinical Study to Evaluate Different Energy-based Devices for Aesthetic Treatments.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06111482.