Evaluating energy-based devices for treating skin conditions

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

This study is testing different energy-based devices to see if they can safely and effectively treat various skin conditions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Cynosure, Inc. (Industry-sponsored)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (Westford, Massachusetts)
• Trial ID: NCT06111482 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety and effectiveness of various energy-based devices, including intense pulsed light and radiofrequency technologies, for treating unwanted dermatologic conditions. Up to 50 participants will be enrolled at a single center and divided into four groups, with the possibility of individuals participating in multiple groups after a specified interval. The study will monitor the outcomes of these treatments to determine their performance in a controlled setting.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 22 and older who are willing to undergo at least one treatment with the study devices.

Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions that affect healing may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with new, effective options for treating dermatologic conditions.

How similar studies have performed: Other studies have shown promise with similar energy-based treatment approaches, indicating potential for success in this area.

Eligibility criteria

Inclusion Criteria:

* A healthy male or female 22 years of age or older.
* Willing to undergo at least 1 treatment with the study device(s).
* Understands and accepts obligation not to receive any other procedures in the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document

Exclusion Criteria:

* Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
* Takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
* Is using systemic steroids (e.g., prednisone, dexamethasone) prior to or during the course of treatment.
* Is receiving or has received gold therapy.
* Is taking medications that alter the wound-healing response or has a history of healing problems.
* Has an active localized or systemic infection, or an open wound in area being treated.
* Has a significant systemic illness, such as lupus, or an illness localized in area being treated.
* Has a seizure disorders triggered by light.
* Has a history of skin photosensitivity disorders.
* Has a history of hypertrophic scars or keloid formation.
* Has a history of radiation therapy in area to be treated.
* Received fillers or neurotoxin injections in the treatment area within the past 2 weeks.
* Has had a chemical or mechanical epilation within the last six weeks.
* Currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months to entering this study.
* Has any condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Radiofrequency Device Only:

* Has a Pacemaker
* Has any embedded electronic devices that give or receive a signal.
* Has electronic implants, such as Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant.
* Is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area.
* Has nerve insensitivity to heat in the treatment area or in the neutral pad placement area.
* Is allergic to topical anesthetic

Where this trial is running

Westford, Massachusetts

• Cynosure — Westford, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Sean Doherty — Cynosure, LLC
• Study coordinator: Jamie Trimper

Conditions Dermatologic Conditions