39 Participants Needed

BTL-785F Device for Wrinkles

Recruiting at 2 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to investigate the effect of the BTL-785F device (with BTL-785-4-4 tip on BTL-785-4 applicator) on the improvement of skin quality and texture on the face and neck in healthy adult volunteers. The main question it aims to answer is:Whether the BTL-785F device (with BTL-785-4-4 tip on BTL-785-4 applicator) is able to improve skin quality 3 months post-treatment, as assessed by two-dimensional and three-dimensional photographs.Participants will complete three treatments, and two follow-up visits.

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.

Is the BTL-785F device safe for treating wrinkles?

Botulinum toxin A (BTX-A), which may be similar to BTL-785F, has been used safely for facial treatments for over 10 years. Common side effects include temporary muscle weakness, but no serious long-term issues have been reported.12345

How does the BTL-785F treatment for wrinkles differ from other treatments?

The BTL-785F treatment is unique because it likely involves a novel device or technology, but specific details about its mechanism or components are not provided in the available research. Other treatments for wrinkles often involve radiofrequency, light-based therapies, or botulinum toxin, which work by stimulating collagen or relaxing muscles.678910

What data supports the effectiveness of the BTL-785F treatment for wrinkles?

Research shows that fractional radiofrequency treatments, similar to the BTL-785F, have been effective in improving skin texture and reducing wrinkles. Additionally, broadband light treatments, which are non-invasive, have been shown to stimulate collagen and elastin, helping to rejuvenate the skin.6791011

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

I am over 30 and want to improve my skin quality on my face and neck.
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 agree not to have any facial or neck treatments other than what this study involves.
See 1 more

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
See 29 more

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?
1Treatment groups
Experimental Treatment
Group I: Treatment with BTL-785FExperimental Treatment1 Intervention
Three (3) treatment sessions will be applied to the subjects' face and neck using 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+

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.
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

A split-face randomized controlled trial of treatment with broadband light for enlarged facial pores. [2022]
Safety and efficacy of fractional bipolar radiofrequency treatment in Fitzpatrick skin types V-VI. [2019]
The effect of full-face broadband light treatments alone and in combination with bilateral crow's feet Botulinum toxin type A chemodenervation. [2019]
Clinical and histologic evaluation of a fractional radiofrequency treatment of wrinkles and skin texture with novel 1-mm long ultra-thin electrode pins. [2022]
The Efficacy and Safety of Fractional CO₂ Laser Combined with Topical Type A Botulinum Toxin for Facial Rejuvenation: A Randomized Controlled Split-Face Study. [2022]
Sixth nerve palsy following botulinum toxin injection for facial rejuvenation. [2017]
Adverse Events of Botulinum Toxin Type A in Facial Rejuvenation: A Systematic Review and Meta-Analysis. [2022]
Comparison of botulinum toxins A and B in the aesthetic treatment of facial rhytides. [2019]
Botulinum toxin type B (MyoBloc) in the management of hyperkinetic facial lines. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of Intradermal Injection of Botulinum Toxin A for Facial Lifting. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of a novel flash lamp system (FLS) incorporating optimal spectral filtration for the treatment of photoaging. [2005]
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