BTL-785F Device for Wrinkles

No longer recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BTL Industries Ltd.

Must not be taking: Isotretinoin, Tretinoin, Anticoagulants, NSAIDs

Disqualifiers: Cancer, Cardiovascular diseases, Autoimmune, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6-18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device called BTL-785F, designed to enhance skin quality and texture on the face and neck. Participants will undergo three treatments and attend two follow-up visits to assess improvements in skin appearance three months after treatment. The trial seeks healthy adults over 30 who wish to improve their facial and neck skin quality and texture and can refrain from other facial treatments during the study. As an unphased trial, this study offers participants the opportunity to be among the first to experience potential improvements in skin quality and texture.

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

The trial does not specify if you need to stop taking your current medications, but you cannot use isotretinoin or tretinoin-containing medications, non-steroidal anti-inflammatory drugs one week before and after each treatment, or any immunosuppressive medications. It's best to discuss your current medications with the trial team.

What prior data suggests that the BTL-785F device is safe for improving skin quality?

Research has shown that the BTL-785F device has undergone safety testing in several studies. These studies focus on its use for non-invasive wrinkle treatment. The device uses energy to tighten the skin and boost collagen production. Reports from these studies suggest that the method is generally safe and effective for reducing wrinkles. Additionally, the BTL-785F device meets established electrical safety standards, ensuring it operates safely without causing harm. While these findings are promising, individual responses to treatments may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BTL-785F device is unique because it uses a cutting-edge technology that delivers non-invasive radiofrequency energy to target wrinkles. Unlike traditional options like topical creams or surgical procedures, this device stimulates collagen production directly beneath the skin without the need for incisions or downtime. Researchers are excited because it offers the potential for faster, visible improvements in skin texture and firmness, providing a more convenient and comfortable alternative to existing treatments.

What evidence suggests that the BTL-785F device is effective for improving skin quality?

Research shows that the BTL-785F device, which participants in this trial will receive, may help reduce facial wrinkles. Studies have found a noticeable improvement in wrinkle appearance, with at least a 1.0-point reduction on a scale measuring wrinkle depth and skin texture. This device treats wrinkles without surgery. Early results suggest it can make skin smoother and firmer. Safety tests have revealed no major concerns, supporting its potential to improve skin appearance. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to improve the quality and texture of their skin on the face and neck. It's not specified, but typically participants should not have any serious health issues that could affect the treatment outcome.

Inclusion Criteria

Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form

I am over 30 and want to improve my skin quality on my face and neck.

I agree not to have any facial or neck treatments other than what this study involves.

Exclusion Criteria

I have an infection in the area that needs treatment.

Permanent implant in the treated area

Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks

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 three treatment sessions with the BTL-785F device on the face and neck

6-18 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with satisfaction and safety assessments

3 months

2 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term safety and efficacy outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• BTL-785F

Trial Overview The BTL-785F device with a specific tip and applicator is being tested for its ability to enhance skin appearance. Participants will undergo three treatments and be evaluated using photos taken before and after these sessions, up to three months post-treatment.

How Is the Trial Designed?

Group I: Treatment with BTL-785F Experimental Treatment 1 Intervention

Three (3) treatment sessions will be applied to the subjects' face and neck using 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

A meta-analysis of 16 trials involving 42,405 participants found that patients receiving Botulinum toxin A (BTX-A) for facial wrinkles experienced significantly more adverse events (AEs) compared to those receiving a placebo, indicating a need for caution in its use.

Specific adverse events associated with BTX-A, particularly in frown wrinkle treatments, included headaches, eyelid ptosis, and heavy eyelids, highlighting the importance of understanding the safety profile and potential side effects for injectors and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events of Botulinum Toxin Type A in Facial Rejuvenation: A Systematic Review and Meta-Analysis. Jia, Z., Lu, H., Yang, X., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05524779

BTL-785F Device for Non-invasive Reduction of Wrinkles ... 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 treatment of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04447963

Evaluation of Safety and Efficacy of the BTL-785F Device ... The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis ...

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

BTL-785F Device for Non-invasive Treatment of Wrinkles ... This trial is testing a special device that treats facial wrinkles without surgery. It targets people who want to reduce their wrinkles without undergoing ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04447963?keyword=%22Wrinkle%22

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

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K193201.pdf

August 21, 2020 BTL Industries, Inc. David Chmel VP of ... Any differences between the predicate devices and BTL-785F device have no significant influence on safety or effectiveness of the BTL-785F ...

6. ctv.veeva.com ctv.veeva.com/study/clinical-and-histological-evaluation-of-btl-785f-device-for-non-invasive-treatment-of-face

Clinical and Histological Evaluation of BTL-785F Device for ... This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-7 applicator of the BTL-785F system for non-invasive ...