Skin LaxityNCT05929625
Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation
A study testing BTL-585-2 RF+US and BTL-585-2 RF in people with Skin Laxity, 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 radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- BTL-585-2 RF+US and BTL-585-2 RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2020to 31 May 2022
- 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 and facial skin laxity
- 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 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 26Show 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
- Acute neuralgia and neuropathy
- Kidney or liver failure
- Sensitivity disorders in the treatment area
- Varicose veins, pronounced edemas
- 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
BOYD Beauty
Birmingham, Michigan, 48009
Refresh Dermatology
Houston, Texas, 77081
About this study
This study will evaluate the clinical efficacy, safety and the performance of radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) 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 radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) 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. Skin hydration and elasticity in the treatment area will be measured. In addition photographs of the treated area will be taken.
The treatment administration phase in both study groups will consist of four (4) treatment visits, delivered 7 - 14 days apart. Group A will receive treatment with active ultrasound (ON) and the intensity of radiofrequency will be set to a maximum tolerable level. The group B will receive treatment with the intensity of radiofrequency set to a maximum tolerable level, but without active ultrasound (OFF).
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-585F device.
At the last therapy visit, photographs of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in. Skin hydration and elasticity in the treatment area will be measured.
- Conditions
- Skin Laxity
- Being tested
- BTL-585-2 RF+US, BTL-585-2 RF
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-585-2 RF+USDevice
The subjects of RF+US group will receive four simultaneous RF+US treatments of the entire face area including forehead, upper and lower cheeks and area around eyes.
BTL-585-2 RFDevice
The subjects of RF only study group will receive four RF treatments of the entire face area including forehead, upper and lower cheeks and area around eyes.
| Study group | Role | What they receive |
|---|---|---|
| RF+US group | Experimental | Subjects will be treated with the subject device using both, radiofrequency and ultrasound energies simultaneously with regular treatment settings. Receives: Device: BTL-585-2 RF+US |
| RF only group | Experimental | Subjects will be treated with the subject device using only radiofrequency energy with regular treatment settings. Receives: Device: BTL-585-2 RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Wrinkle Severity Change assessed according to the Fitzpatrick Wrinkle and Elastosis Scale (FWES) up to 3 months posttreatment follow-up
The Fitzpatrick Wrinkle and Elastosis Scale is a clinically validated assessment tool and will be used to assess skin wrinkle severity and elastosis on a scale from 1 to 9 (minimum 1 and maximum 9), where the lower score is considered better.
Measured: 3 months
Change in overall facial appearance assessed according to the Global Aesthetic Improvement Scale (GAIS) up to 3 months posttreatment follow-up
Three independent evaluators will evaluate before and after photographs and grade them for change. Using the same photographs, they will evaluate changes in overall facial appearance according to the Global Aesthetic Improvement scale.
For reporting of outcomes, the higher the GAIS value, the greater the improvement in the range -1 to 3.
The following criteria will be used:
Grade 3: Very Much Improved Grade 2: Much Improved Grade 1: Improved Grade 0: No Change Grade -1: Worse.
Measured: 3 months
Secondary outcomes (3)
Assessment of the safety profile by recording adverse events and assessing the subject's discomfort and pain
Occurrence of adverse events and side effects will be observed. Subjects experiencing a treatment-related adverse event (AE) in the first 90 days post-treatment, incidence/rates described as a percentage of the subjects.
Measured: 3 months
Assessment of therapy comfort after the final study treatment based on a Therapy Comfort Questionnaire
A 5-point Likert scale Therapy Comfort Questionnaire and a numerical analog scale (NAS) will be used for evaluating comfort during the treatment sessions. The answers to the questions related to the subjects' overall skin and facial appearance will vary from "strongly agree (5)" to "strongly disagree (1)". The Therapy Comfort Questionnaire will be given to subjects at the final therapy visit.
Measured: up to 8 weeks
Assessment of subject's satisfaction with study treatment using the Subject Satisfaction Questionnaire
A 5-point Likert scale Subject Satisfaction Questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. The answers to the questions related to the subjects' overall skin and facial appearance will vary from "strongly agree (5)" to "strongly disagree (1)". Subject satisfaction will be assessed after the last therapy visit and during the 1-month and 3-month follow-up visits.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start28 Oct 2020
- Primary completion23 Feb 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 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
- NCT05929625
- Sponsor's protocol ID
- BTL-585F_100
- Status last verified
- Jun 2023
- First submitted
- 11 Apr 2023
- Last updated
- 3 Jul 2023
- 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 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation
- ClinicalTrials.gov ID
- NCT05929625
- Acronym / sponsor ID
- BTL-585F_100
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 Jul 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 radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) treatment visits and two to three follow-up visits.
Detailed description
This study will evaluate the clinical efficacy, safety and the performance of radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) 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. Skin hydration and elasticity in the treatment area will be measured. In addition photographs of the treated area will be taken.
The treatment administration phase in both study groups will consist of four (4) treatment visits, delivered 7 - 14 days apart. Group A will receive treatment with active ultrasound (ON) and the intensity of radiofrequency will be set to a maximum tolerable level. The group B will receive treatment with the intensity of radiofrequency set to a maximum tolerable level, but without active ultrasound (OFF).
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-585F device.
At the last therapy visit, photographs of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in. Skin hydration and elasticity in the treatment area will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings.
| Arm | Type | Receives |
|---|---|---|
| RF+US group | Experimental | Device: BTL-585-2 RF+USSubjects will be treated with the subject device using both, radiofrequency and ultrasound energies simultaneously with regular treatment settings. |
| RF only group | Experimental | Device: BTL-585-2 RFSubjects will be treated with the subject device using only radiofrequency energy with regular treatment settings. |
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 and facial skin laxity
- 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 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 (26 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-585-2 RF+USThe subjects of RF+US group will receive four simultaneous RF+US treatments of the entire face area including forehead, upper and lower cheeks and area around eyes. | Device | RF+US group |
| BTL-585-2 RFThe subjects of RF only study group will receive four RF treatments of the entire face area including forehead, upper and lower cheeks and area around eyes. | Device | RF only group |
Primary outcome
Overall Wrinkle Severity Change assessed according to the Fitzpatrick Wrinkle and Elastosis Scale (FWES) up to 3 months posttreatment follow-up
Time frame: 3 months
The Fitzpatrick Wrinkle and Elastosis Scale is a clinically validated assessment tool and will be used to assess skin wrinkle severity and elastosis on a scale from 1 to 9 (minimum 1 and maximum 9), where the lower score is considered better.
Change in overall facial appearance assessed according to the Global Aesthetic Improvement Scale (GAIS) up to 3 months posttreatment follow-up
Time frame: 3 months
Three independent evaluators will evaluate before and after photographs and grade them for change. Using the same photographs, they will evaluate changes in overall facial appearance according to the Global Aesthetic Improvement scale. For reporting of outcomes, the higher the GAIS value, the greater the improvement in the range -1 to 3. The following criteria will be used: Grade 3: Very Much Improved Grade 2: Much Improved Grade 1: Improved Grade 0: No Change Grade -1: Worse.
3 secondary outcomes
Assessment of the safety profile by recording adverse events and assessing the subject's discomfort and pain
Time frame: 3 months
Assessment of therapy comfort after the final study treatment based on a Therapy Comfort Questionnaire
Time frame: up to 8 weeks
Assessment of subject's satisfaction with study treatment using the Subject Satisfaction Questionnaire
Time frame: 3 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 3 Jul 2023.
- 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-585-2 RF+US and BTL-585-2 RF in people with Skin Laxity, 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 26 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 3 Jul 2023. 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?
Overall Wrinkle Severity Change assessed according to the Fitzpatrick Wrinkle and Elastosis Scale (FWES) up to 3 months posttreatment follow-up (time frame: 3 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 3 Jul 2023.