23 Participants Needed

BTL-785F Device for Non-invasive Treatment of Wrinkles and Improvement of the Face Appearance

Recruiting at 1 trial location
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a special device that treats facial wrinkles without surgery. It targets people who want to reduce their wrinkles without undergoing invasive procedures. The device works by using energy to tighten the skin and boost collagen production. These methods have been reported to be safe and effective for the non-invasive treatment of wrinkles and overall facial rejuvenation.

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 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 treatment, shows promise in cancer immunotherapy. This approach has been linked to encouraging preliminary results in clinical trials, especially when combined with other therapies targeting immune checkpoints like PD-1/PD-L1.12345

What safety data exists for BTL-785-7 Treatment (also known as Bruton's tyrosine kinase inhibitors)?

Bruton's tyrosine kinase inhibitors, which may include BTL-785-7 Treatment, have been associated with some cardiac risks, such as atrial fibrillation (irregular heartbeat). In studies of similar treatments, common side effects included headache, diarrhea, and fatigue, while serious side effects like pneumonia were less common. The safety profile varies between different generations of these inhibitors, with newer versions having fewer cardiovascular issues but more blood-related and digestive side effects.678910

Eligibility Criteria

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
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Timeline

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)

Treatment Details

Interventions

  • BTL-785-7 Treatment
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BTL-785-7 TreatmentExperimental Treatment1 Intervention
Treatment with the BTL-785-7 applicator to the BTL-785F system.

Find a Clinic Near You

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials
59
Recruited
2,000+

Findings from Research

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.
Pharmacovigilance analysis of cardiac risks associated with Bruton tyrosine kinase inhibitors.Zhai, Y., Hu, F., Shi, W., et al.[2023]
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.
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.
The safety of Bruton's tyrosine kinase inhibitors in B-cell malignancies: A systematic review.Arustamyan, M., Kibrik, P., Hatipoglu, D., et al.[2022]

References

Butyrophilin-like 2 modulates B7 costimulation to induce Foxp3 expression and regulatory T cell development in mature T cells. [2017]
Friend or Foe: Prognostic and Immunotherapy Roles of BTLA in Colorectal Cancer. [2022]
Distinct expression and inhibitory function of B and T lymphocyte attenuator on human T cells. [2007]
BTLA Expression in Stage I-III Non-Small-Cell Lung Cancer and Its Correlation with PD-1/PD-L1 and Clinical Outcomes. [2022]
Beyond the anti-PD-1/PD-L1 era: promising role of the BTLA/HVEM axis as a future target for cancer immunotherapy. [2023]
Pharmacovigilance analysis of cardiac risks associated with Bruton tyrosine kinase inhibitors. [2023]
A phase I trial of PRN1008, a novel reversible covalent inhibitor of Bruton's tyrosine kinase, in healthy volunteers. [2021]
Diagnosis and Management of Cardiovascular Effects of Bruton's Tyrosine Kinase Inhibitors. [2023]
Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in mature B-cell malignancies. [2022]
The safety of Bruton's tyrosine kinase inhibitors in B-cell malignancies: A systematic review. [2022]
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