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Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles

Primary Purpose

Acne, Wrinkle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BTL-585F
Sponsored by
BTL Industries Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male or female subjects over 21 years of age seeking treatment and reduction of facial wrinkles or acne scars Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form Presence of clearly visible wrinkles or acne scars in the treated area when the face is relaxed as deemed appropriate by the Investigator Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken Exclusion Criteria: Bacterial or viral infection, acute inflammations Impaired immune system Isotretinoin in the past 12 months Skin related autoimmune diseases Radiation therapy and/or chemotherapy Poor healing and unhealed wounds in the treatment area Metal implants Permanent implant in the treated area Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 6 months prior to the treatment Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles History of any type of cancer Active collagen diseases Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis) Pregnancy/nursing or IVF procedure History of bleeding coagulopathies, use of anticoagulants Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea Any surgical procedure in the treatment area within the last three months or before complete healing Poorly controlled endocrine disorders, such as diabetes History of skin disorders, keloids, very dry and fragile skin Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks Botox®/collagen/fat injections or other injected bio-material in the treated area within three months prior to the treatment Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session Treating over tattoo or permanent make-up Treating over eyelids or the lips Patients with allergy to anesthetics should not be treated under anesthesia Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion Unwillingness/inability to not change their usual cosmetics and especially not to use ani-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study

Sites / Locations

  • Precision Skin Institute
  • Yael Halaas, M.D., FACS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acne scars

Facial wrinkles

Arm Description

All subjects will be treated with the BTL-585F system. Parameters' settings should be individually evaluated by the operator based on the treatment area and on the patient's medical and wound healing history. Parameters can be modified during subsequent visits, as per the practitioner's discretion.

All subjects will be treated with the BTL-585F system. Parameters' settings should be individually evaluated by the operator based on the treatment area and on the patient's medical and wound healing history. Parameters can be modified during subsequent visits, as per the practitioner's discretion.

Outcomes

Primary Outcome Measures

Change in wrinkle severity
Evaluation of wrinkle severity based on photographs before and after the study procedure.
Change in acne scars
Evaluation of improvement in acne scars based on photographs before and after the study procedure.

Secondary Outcome Measures

Safety of the BTL-585F device with BTL-585-4 applicator
Evaluation of the safety of the BTL-585F device with BTL-585-4 applicator for non-invasive reduction of wrinkles and treatment of acne scars by monitoring of adverse events.

Full Information

First Posted
April 12, 2023
Last Updated
April 12, 2023
Sponsor
BTL Industries Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05827510
Brief Title
Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles
Official Title
Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BTL Industries Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the clinical efficacy, safety and the performance of the fractional radiofrequency delivered by the BTL-585-4 applicator of the BTL-585F system for non-invasive treatment of acne scars and facial wrinkles. The study is a prospective multicenter open label two-arm study. The subjects will be enrolled and assigned into two study groups, according to their indication; group A (acne scars) and B (facial wrinkles), each study group will receive treatment of different conditions. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.
Detailed Description
This study will evaluate the clinical efficacy, safety and the performance of the fractional radiofrequency delivered by the BTL-585-4 applicator of the BTL-585F system for non-invasive treatment of acne scars and facial wrinkles. The study is a prospective multicenter open label two-arm study. The subjects will be enrolled and assigned into two study groups, according to their indication; group A (acne scars) and B (facial wrinkles), each study group will receive treatment of different conditions. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits. At the baseline visit, health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed. In addition photographs of the treated area will be taken. The treatment administration phase in both study groups will consist of three (3) treatment visits, delivered 2-5 weeks apart. Subjects of both groups will receive treatment with the insulated or non-insulated microneedle tip (BTL-585-4-5 or BTL-585-4-6), depending on patients' skin sensitivity, followed by the application of superficial tip 32 (BTL-585-4-7) or 64 (BTL-585-4-8), depending on the size of the treatment site. Treatment settings will be adjusted individually according to the severity of the subjects' condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Wrinkle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The subjects will be enrolled and assigned into two study groups, according to their indication; group A (acne scars) and B (facial wrinkles), each study group will receive treatment of different conditions.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acne scars
Arm Type
Experimental
Arm Description
All subjects will be treated with the BTL-585F system. Parameters' settings should be individually evaluated by the operator based on the treatment area and on the patient's medical and wound healing history. Parameters can be modified during subsequent visits, as per the practitioner's discretion.
Arm Title
Facial wrinkles
Arm Type
Experimental
Arm Description
All subjects will be treated with the BTL-585F system. Parameters' settings should be individually evaluated by the operator based on the treatment area and on the patient's medical and wound healing history. Parameters can be modified during subsequent visits, as per the practitioner's discretion.
Intervention Type
Device
Intervention Name(s)
BTL-585F
Intervention Description
BTL-585F device with BTL-585-4 applicator
Primary Outcome Measure Information:
Title
Change in wrinkle severity
Description
Evaluation of wrinkle severity based on photographs before and after the study procedure.
Time Frame
5 months
Title
Change in acne scars
Description
Evaluation of improvement in acne scars based on photographs before and after the study procedure.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Safety of the BTL-585F device with BTL-585-4 applicator
Description
Evaluation of the safety of the BTL-585F device with BTL-585-4 applicator for non-invasive reduction of wrinkles and treatment of acne scars by monitoring of adverse events.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male or female subjects over 21 years of age seeking treatment and reduction of facial wrinkles or acne scars Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form Presence of clearly visible wrinkles or acne scars in the treated area when the face is relaxed as deemed appropriate by the Investigator Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken Exclusion Criteria: Bacterial or viral infection, acute inflammations Impaired immune system Isotretinoin in the past 12 months Skin related autoimmune diseases Radiation therapy and/or chemotherapy Poor healing and unhealed wounds in the treatment area Metal implants Permanent implant in the treated area Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 6 months prior to the treatment Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles History of any type of cancer Active collagen diseases Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis) Pregnancy/nursing or IVF procedure History of bleeding coagulopathies, use of anticoagulants Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea Any surgical procedure in the treatment area within the last three months or before complete healing Poorly controlled endocrine disorders, such as diabetes History of skin disorders, keloids, very dry and fragile skin Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks Botox®/collagen/fat injections or other injected bio-material in the treated area within three months prior to the treatment Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session Treating over tattoo or permanent make-up Treating over eyelids or the lips Patients with allergy to anesthetics should not be treated under anesthesia Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion Unwillingness/inability to not change their usual cosmetics and especially not to use ani-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study
Facility Information:
Facility Name
Precision Skin Institute
City
Davie
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Facility Name
Yael Halaas, M.D., FACS
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles

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