WrinkleNCT05519124
BTL-785F Device for Non-invasive Reduction of Wrinkles
A study testing BTL-785-7 in people with Wrinkle, run by BTL Industries Ltd. at 2 sites in United States.
Trial summary
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 facial wrinkles. The study is a multicenter single-arm, open-label, interventional study. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- BTL-785-7
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Nov 2021to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects over 21 years of age seeking treatment for reduction of wrinkles
- Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
- 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
Who cannot join
- Local bacterial or viral infection in the area to be treated
- Local acute inflammation in the area to be treated
- Impaired immune system caused by any immunosuppressive illness, disease or medication1
- Isotretinoin and tretinoin-containing medication use in the past 12 months
- Skin related autoimmune diseases
- Radiation therapy and/or chemotherapy
Show all 32Show fewer
- Poor healing and unhealed wounds in the treatment area
- Metal implants
- Permanent implant in the treated area
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
- Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
- History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
- History of any type of cancer
- Active collagen diseases
- Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)1
- Pregnancy/nursing or IVF procedure
- History of bleeding coagulopathies, use of anticoagulants
- Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
- Any surgical procedure in the treatment area within the last three months or before complete healing
- Poorly controlled endocrine disorders, such as diabetes
- Acute neuralgia and neuropathy
- Kidney or liver failure
- Nerve insensitivity (sensitivity disorders) to heat in the treatment area
- Varicose veins, pronounced edemas1
- Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
- Unwillingness/inability to not change their usual cosmetics and especially not to use anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
- Electroanalgesia without exact diagnosis of pain etiology
- Application in the area of chest, heart or over the eyes
- Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
- Blood vessels and lymphatic vessels inflammation
- Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yael Halaas M.D.
New York, New York, 10022
Gentile Facial Plastic Surgery & Aesthetic Laser Center
Youngstown, Ohio, 44512
About this study
Official title: Evaluation of Safety and Efficacy of the 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 facial wrinkles. The study is a multicenter single-arm, open-label, interventional study.
Read the detailed description
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 facial wrinkles. The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two 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.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.
Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups.
Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment.
- Conditions
- Wrinkle
- Being tested
- BTL-785-7
- Keywords
- wrinkle, skin laxity
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-785-7Device
Treatment with the BTL-785-7 applicator to the BTL-785F system.
| Study group | Role | What they receive |
|---|---|---|
| BTL-785-7 Treatment | Experimental | Not described Receives: Device: BTL-785-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninvasive Treatment Of Wrinkles
Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. Baseline and post-treatment photographs will be evaluated. A statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale should be achieved.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start3 Nov 2021
- Primary completion30 Apr 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519124
- Sponsor's protocol ID
- BTL-785_CTUS400
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gentile R, Halaas Y. Novel Approach to Facial Rejuvenation by Treating Cutaneous and Soft Tissue for Wrinkles Reduction: First Experience from Multicenter Clinical Trial. Facial Plast Surg Aesthet Med. 2024 Jan-Feb;26(1):1-6. doi: 10.1089/fpsam.2023.0015. Epub 2023 Jun 28.
PubMed 37379470
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles
- ClinicalTrials.gov ID
- NCT05519124
- Acronym / sponsor ID
- BTL-785_CTUS400
- Conditions
- Wrinkle
- Keywords
- wrinkle, skin laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 facial wrinkles. The study is a multicenter single-arm, open-label, interventional study.
Detailed description
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 facial wrinkles. The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two 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.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.
Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups.
Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTL-785-7 Treatment | Experimental | Device: BTL-785-7 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects over 21 years of age seeking treatment for reduction of wrinkles
- Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
- 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
Key exclusion criteria (32 listed)
- Local bacterial or viral infection in the area to be treated
- Local acute inflammation in the area to be treated
- Impaired immune system caused by any immunosuppressive illness, disease or medication1
- Isotretinoin and tretinoin-containing medication use in the past 12 months
- Skin related autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTL-785-7Treatment with the BTL-785-7 applicator to the BTL-785F system. | Device | BTL-785-7 Treatment |
Primary outcome
Noninvasive Treatment Of Wrinkles
Time frame: 4 months
Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. Baseline and post-treatment photographs will be evaluated. A statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale should be achieved.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 37379470Gentile R, Halaas Y. Novel Approach to Facial Rejuvenation by Treating Cutaneous and Soft Tissue for Wrinkles Reduction: First Experience from Multicenter Clinical Trial. Facial Plast Surg Aesthet Med. 2024 Jan-Feb;26(1):1-6. doi: 10.1089/fpsam.2023.0015. Epub 2023 Jun 28.
- Individual participant dataSharing planned: No
Related trials for Wrinkle
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL-785-7 in people with Wrinkle, run by BTL Industries Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noninvasive Treatment Of Wrinkles (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05519124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.