Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

Cynosure

Status: Completed

Conditions: Stretch Marks; Acne Scars; Acne; Enlarged Pores; Crepey Skin; Fine Lines; Loose Skin; Wrinkle

Treatments: Device: Potenza

Study type: Interventional

Funder types: Industry

Identifiers

NCT05097157

CYN19-RF-MN-01

Details and patient eligibility

About

Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Enrollment: 79 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A healthy, non-smoking male or female between the age of 18-55 years old.
• Fitzpatrick skin type I to VI.
• Understands and accepts obligation not to receive any other procedures on 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 pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.

• The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.

• The subject has physical problems such as cardiovascular disorders.

• The subject has a pacemaker.

• The subject had previous use of gold thread skin rejuvenation.

• The subject has skin infections.

• The subject has any of the following conditions:

  • Diabetes
  • Epilepsy
  • Acute disease
  • Dermatitis

• Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.

• The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

Treatment with Device

Experimental group

Description:

Subjects received up to 5 treatments with the device, spaced 4 weeks apart.

Treatment:

Device: Potenza