N/A
Completed N=10
Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles
Acne Scars - Mixed Atrophic and Hypertrophic · Wrinkle
Source: ClinicalTrials.gov NCT04057768 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment — 5.97; 5.78 units on a scale
Summary
The objective of this clinical study is to evaluate the efficacy of fractional RF for the treatment and reduction of acne scarring or facial wrinkles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment |
5.97; 5.78 | — |
| PRIMARY Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment |
0.4 | — |
| SECONDARY Subject Satisfaction |
3.22; 3.20 | — |
| SECONDARY Subject Scale - Wong Baker FACES Pain Scale |
3.93 | — |
| SECONDARY Subject Scale - 5 Point Scale for Treatment Tolerability |
3.10 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring or wrinkles.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
Exclusion Criteria
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- Subjects with any implantable metal device in the treatment area
- Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
- Current or history of any kind of cancer, or dysplastic nevi
- Severe concurrent conditions, such as cardiac disorders.
- Pregnancy or intending to become pregnant during the study and nursing.
- Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
- History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
- Poorly controlled endocrine disorders, such as diabetes.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
- History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
- Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
- Use of isotretinoin (Accutane®) or other systemic retinoids within six months prior to treatment or as per investigators discretion.
- Any surgical procedure in the treatment area within the last six months or before complete healing.
- Treating over tattoo or permanent makeup.
- Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
Data sourced from ClinicalTrials.gov (NCT04057768). 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. Informational only — not medical advice.