WrinkleNCT04447963
Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles
A study testing Non-invasive treatment of facial wrinkles in people with Wrinkle, run by BTL Industries Ltd. at 1 site in Bulgaria.
Trial summary
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 wrinkles. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Non-invasive treatment of facial wrinkles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBulgaria
- Study dates
- 15 Jun 2020to 28 Jun 2021
- 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 to 70 years
- 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 and reduction of facial 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
- Bacterial or viral infection, acute inflammations
- Impaired immune system
- Isotretinoin in the past 12 months
- Skin related autoimmune diseases
- Radiation therapy and/or chemotherapy
- Poor healing and unhealed wounds in the treatment area
Show all 27Show fewer
- 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 6 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 any type of cancer
- Active collagen diseases
- Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
- 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
- Sensitivity disorders in the treatment area
- Varicose veins, pronounced edemas
- 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 ani-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
- Unwillingness/inability to abstain from cosmetic procedures in the treated area at least 15 days before every examination with the facial image analysis system VISIA
- 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
1 site in 1 country.
About this study
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 wrinkles.
Read the detailed description
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 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 three (3) treatment visits and two follow-up visits. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
Follow-ups visits at 3 months and 6 months after the final treatment will be held.
- Conditions
- Wrinkle
- Being tested
- Non-invasive treatment of facial wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive treatment of facial wrinklesDevice
Application of radiofrequency field which provides controlled heating to the skin.Therapeutic effect is observed when the tissue temperature reaches 40-45 degrees Celsius.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive treatment of wrinkles and rhytids | Experimental | The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete three (3) 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 three (3) treatment visits, delivered 1 week apart.
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device. Receives: Device: Non-invasive treatment of facial wrinkles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale
Gathering of clinical evidence that the Device is able to achieve reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. 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 Scale score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline.
Measured: 3 months
Secondary outcomes (2)
Assess safety profile by recording of adverse events
All AEs including local and systemic reactions not meeting the criteria for "serious adverse events" will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis, which would include MD, DDS, DMD, PA, Nurse Practitioner or DO), and time of resolution/stabilization of the event. All AEs occurring during the study must be documented appropriately regardless of relationship to study device. All AEs will be followed to adequate resolution.
Measured: 7 months
Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire
Every subject who completed the treatment will be asked to fill in the Satisfaction Questionnaire at the 3 months follow-up and the 6 months follow-up. This evaluation should reflect overall satisfaction with the results compared to therapy comfort, experienced pain, duration, and application convenience.
Subjects will be asked: "Overall how are you satisfied with the therapy?" 1 = very satisfied; 2 = satisfied; 3 = neither/nor; 4 = unsatisfied; 5 = very unsatisfied.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start15 Jun 2020
- Primary completion31 Mar 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evgeni Hristozov, MD, Principal investigator, Dermatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447963
- Sponsor's protocol ID
- BTL-785F_WRI
- Status last verified
- Nov 2021
- First submitted
- 22 Jun 2020
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. 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
- NCT04447963
- Acronym / sponsor ID
- BTL-785F_WRI
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 25 Jun 2020 (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 BTL-785-2 applicator for non-invasive treatment of facial wrinkles.
Detailed description
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 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 three (3) treatment visits and two follow-up visits. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
Follow-ups visits at 3 months and 6 months after the final treatment will be held.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive treatment of wrinkles and rhytids | Experimental | Device: Non-invasive treatment of facial wrinklesThe subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete three (3) 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 three (3) treatment visits, delivered 1 week apart. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device. |
Who may qualify
- Ages
- 21 to 70 years
- 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 and reduction of facial 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 (27 listed)
- Bacterial or viral infection, acute inflammations
- Impaired immune system
- Isotretinoin in the past 12 months
- Skin related autoimmune diseases
- Radiation therapy and/or chemotherapy
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 |
|---|---|---|
| Non-invasive treatment of facial wrinklesApplication of radiofrequency field which provides controlled heating to the skin.Therapeutic effect is observed when the tissue temperature reaches 40-45 degrees Celsius. | Device | Non-invasive treatment of wrinkles and rhytids |
Primary outcome
Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale
Time frame: 3 months
Gathering of clinical evidence that the Device is able to achieve reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. 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 Scale score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline.
2 secondary outcomes
Assess safety profile by recording of adverse events
Time frame: 7 months
Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire
Time frame: 6 months
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 10 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Evgeni Hristozov, MD principal investigator
Dermatologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive treatment of facial wrinkles in people with Wrinkle, run by BTL Industries Ltd. at 1 site in Bulgaria.
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 27 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. 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?
Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2021.