An interventional study of BTL-585-2 RF+US and BTL-585-2 RF in Skin Laxity, sponsored by BTL Industries Ltd.. Completed at 2 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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.
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.
147 studies on the registry are indexed under Cutis Laxa; 35 are open to participants now.
This study's enrollment of 41 is above the median of 30 across 129 interventional studies indexed under Cutis Laxa.
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Exclusion Criteria:
Subjects will be treated with the subject device using both, radiofrequency and ultrasound energies simultaneously with regular treatment settings.
Device: BTL-585-2 RF+US
Subjects will be treated with the subject device using only radiofrequency energy with regular treatment settings.
Device: BTL-585-2 RF
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.
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.
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.
Time frame: 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.
Time frame: 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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BTL Industries Ltd.