N/A
N=79
Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions
Wrinkle · Fine Lines · Crepey Skin · Acne Scars · Acne
Bottom Line
View on ClinicalTrials.gov: NCT05097157 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Subject Satisfaction — 7; 21; 15; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potenza (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cynosure, Inc.
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Satisfaction |
4; 5; 5; 1; 0; 1 | — |
| PRIMARY Global Aesthetic Improvement Scale Assessment (GAIS) Assessment |
0; 5; 10; 1; 0 | — |
| PRIMARY Subject Satisfaction |
4; 5; 5; 1; 0; 1 | — |
| PRIMARY Global Aesthetic Improvement Scale Assessment (GAIS) Assessment |
0; 5; 10; 1; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05097157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.