AcneNCT05827510
Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles
A study testing BTL-585F in people with Acne and Wrinkle, run by BTL Industries Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- BTL-585F
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2020to 10 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Precision Skin Institute
Davie, Florida, 33328
Yael Halaas, M.D., FACS
New York, New York, 10022
About this study
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.
Read the 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.
- Being tested
- BTL-585F
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-585FDevice
BTL-585F device with BTL-585-4 applicator
| Study group | Role | What they receive |
|---|---|---|
| Acne scars | Experimental | 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. Receives: Device: BTL-585F |
| Facial wrinkles | Experimental | 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. Receives: Device: BTL-585F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wrinkle severity
Evaluation of wrinkle severity based on photographs before and after the study procedure.
Measured: 5 months
Change in acne scars
Evaluation of improvement in acne scars based on photographs before and after the study procedure.
Measured: 5 months
Secondary outcomes (1)
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start30 Nov 2020
- Primary completion1 Sep 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827510
- Sponsor's protocol ID
- BTL-585F_200
- Status last verified
- Feb 2024
- First submitted
- 12 Apr 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles
- ClinicalTrials.gov ID
- NCT05827510
- Acronym / sponsor ID
- BTL-585F_200
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acne scars | Experimental | Device: BTL-585FAll 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. |
| Facial wrinkles | Experimental | Device: BTL-585FAll 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (29 listed)
- Bacterial or viral infection, acute inflammations
- Impaired immune system
- Isotretinoin in the past 12 months
- Skin related autoimmune diseases
- Radiation therapy and/or chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTL-585FBTL-585F device with BTL-585-4 applicator | Device | Acne scars, Facial wrinkles |
Primary outcome
Change in wrinkle severity
Time frame: 5 months
Evaluation of wrinkle severity based on photographs before and after the study procedure.
Change in acne scars
Time frame: 5 months
Evaluation of improvement in acne scars based on photographs before and after the study procedure.
1 secondary outcome
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL-585F in people with Acne and Wrinkle, run by BTL Industries Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wrinkle severity (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.