BTL-785F Device for Wrinkles

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BTL Industries Ltd.

Must not be taking: Isotretinoin, Anticoagulants

Disqualifiers: Cancer, Cardiovascular diseases, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to reduce facial wrinkles without surgery. The goal is to determine if the BTL-785F system with the BTL-785-7 applicator, a non-invasive treatment, is safe and effective for improving facial appearance. It targets individuals with noticeable wrinkles when their face is relaxed and who seek non-invasive cosmetic treatments. Ideal participants are over 21 years old and can commit to not using other facial treatments during the study. As an unphased trial, this study provides a unique opportunity to explore innovative cosmetic solutions without the commitment of surgery.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking isotretinoin, you must have stopped it at least 12 months before participating.

What prior data suggests that the BTL-785F system with the BTL-785-7 applicator is safe for treating facial wrinkles?

Research has shown that the BTL-785-7 treatment is safe for people. One study tracked patients for three months and found the treatment both safe and effective. Another source noted that this device uses radiofrequency heating and muscle stimulation, which people have generally tolerated well. However, similar treatments, such as certain medications for blood disorders, have been linked to heart risks, including atrial fibrillation (an irregular heartbeat). Always consult a healthcare professional to determine if this treatment is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional wrinkle treatments like creams, injections, or surgical procedures, which can be invasive or require ongoing maintenance, the BTL-785-7 Treatment is non-invasive and utilizes a unique applicator system. Researchers are excited because this device offers a new way to address facial wrinkles and improve appearance without needles or downtime. Its innovative use of energy-based technology targets the skin differently, potentially offering quicker results with greater convenience.

What evidence suggests that the BTL-785-7 applicator is effective for treating facial wrinkles?

Research has shown that the BTL-785-7 treatment, which participants in this trial will receive, helps reduce wrinkles. One study found that 81% of participants experienced significant skin improvement after six sessions. On average, their skin improved by nearly 50%, indicating promising results for wrinkle treatment. Another report confirmed the safety and effectiveness of the BTL-785-7 device, based on follow-up evaluations three months later. These findings suggest that the BTL-785-7 treatment could be an effective non-surgical option for reducing wrinkles. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Healthy male or female subjects over 21 years of age seeking treatment for reduction of wrinkles and overall aesthetic improvement of the face

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive treatment with the BTL-785-7 applicator over four visits, 5-10 days apart

4-6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BTL-785-7 Treatment

How Is the Trial Designed?

Group I: BTL-785-7 Treatment Experimental Treatment 1 Intervention

Treatment with the BTL-785-7 applicator to the BTL-785F system.

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials

59

Recruited

2,000+

Published Research Related to This Trial

Bruton's tyrosine kinase inhibitors (BTKis) are effective in treating B-cell malignancies but are associated with cardiovascular side effects, particularly an increased risk of atrial fibrillation, bleeding, and hypertension.

Newer generations of BTKis may have a lower risk of cardiovascular issues, but long-term safety data is still lacking, highlighting the need for careful management of cardiovascular risk factors in patients undergoing BTKi treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and Management of Cardiovascular Effects of Bruton's Tyrosine Kinase Inhibitors. Aghel, N., Baro Vila, RC., Lui, M., et al.[2023]

A systematic review of 55 studies found that first-generation BTK inhibitors had a significantly higher incidence of cardiovascular adverse events (20.8%) compared to second-generation BTK inhibitors (6.3%).

While second-generation BTK inhibitors showed lower cardiovascular risks, they were associated with higher rates of hematologic/oncologic (62.3% vs. 39.2%) and gastrointestinal side effects (36.9% vs. 28.9%) compared to first-generation inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Bruton's tyrosine kinase inhibitors in B-cell malignancies: A systematic review. Arustamyan, M., Kibrik, P., Hatipoglu, D., et al.[2022]

A study analyzing 10,320 cardiac event reports linked to Bruton tyrosine kinase inhibitors (BTKIs) found that 17.63% of these cases involved death or life-threatening events, indicating significant cardiac risks associated with these medications.

Ibrutinib was identified as having the strongest association with cardiac complications, particularly atrial fibrillation, while acalabrutinib showed a statistically lower risk compared to ibrutinib, highlighting the variability in cardiotoxicity among different BTKIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance analysis of cardiac risks associated with Bruton tyrosine kinase inhibitors. Zhai, Y., Hu, F., Shi, W., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT06274177

Evaluation of the BTL-785F Device for Submental Fat ...

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05831332

Study Details | Safety and Efficacy of the BTL-785F Device ...

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of ...

3.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf22/K222556.pdf

K222556 - David Chmel - accessdata.fda.gov

Based on 3-month follow-ups, the treatment with the BTL-785X device equipped with applicator BTL- 785-7 has shown to be both safe and effective ...

4.

withpower.com

withpower.com/trial/phase-wrinkles-5-2022-85ad0

BTL-785F Device for Non-invasive Treatment of Wrinkles ...

What data supports the effectiveness of the BTL-785-7 treatment? Research suggests that targeting the BTLA/HVEM axis, which is part of the BTL-785-7 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6851770/

Safety and Efficacy of a Non‐Invasive High‐Intensity ...

After the sixth session, 61 out of 75 patients (81.33%) reported significant reduction of their symptoms. The average improvement of 49.93% in ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04447963

Evaluation of Safety and Efficacy of the BTL-785F Device ...

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 applicator for non-invasive treatment of facial ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/K233604.pdf

K233604 T - accessdata.fda.gov

BTL-785-7 hands-free applicators providing treatment by integration of radiofrequency heating and muscle stimulation resulting in induced muscle ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06274177

Evaluation of the BTL-785F Device for Submental Fat ...

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of ...