WrinkleNCT03548025
Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles
A study testing BTL-703 (Treatment group) in people with Wrinkle, run by BTL Industries Ltd. at 1 site in Bulgaria.
Trial summary
The study will evaluate safety and effectivity of the BTL-FR2000 device for the treatment of facial wrinkles. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- BTL-703 (Treatment group)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Mar 2018to 1 Mar 2019
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 22 years
- Voluntarily signed informed consent form
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 chemotherapy
- Poor healing and unhealed wounds in the treatment area
Show all 26Show fewer
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
- 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 any kind of cancer
- Active collagen diseases
- Cardiovascular diseases (such as cardiac and vascular diseases, peripheral arterial disease, thrombophlebitis, thrombosis, etc.)
- 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
- Children under age of 21
- Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks
- Patients with allergy to anesthetics should not be treated under anesthesia
- Botox®/collagen/fat injections or other injected bio-material in the treated area within three months prior to treatment
- Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session
- Treating over tattoo or permanent makeup
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Aesthe Clinic
Sofia
Radina Denkova, MD, aestheclinic@abv.bg
About this study
The study will evaluate safety and effectivity of the BTL-FR2000 device for the treatment of facial wrinkles.
Read the detailed description
Subjects will be photographed at the baseline visit. After the treatment phase, subjects will be invited for two follow-up visits - 3 and 6 months after the last therapy. They will be again photographed.
Three blinded evaluators will be scoring the full face photos according to the Fitzpatrick Wrinkle Severity Scale. The improvement of the scores will be evaluated. Every subject will serve as its own control.
In addition, the occurence of an AE during the whole study, as well as the therapy discomfort during the treatment phase, will be followed.
- Conditions
- Wrinkle
- Being tested
- BTL-703 (Treatment group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-703 (Treatment group)Device
Treatment with BTL-FR2000 Device
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treated group of subjects, serves as its own control Receives: Device: BTL-703 (Treatment group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of facial wrinkles evaluated through the change in the value of the validated scale
Three blinded evaluators will be evaluating the full-face photographs taken at the baseline, last therapy visit and both follow-up visits. They will be evaluating it using the validated Fitzpatrick Wrinkle Severity Scale. According to that scale, subjects are divided in three categories (I, II, III) corresponding to mild, moderate, and severe wrinkling, and degree of elastosis. In addition, a score of 1 to 9 (a linear sliding scale to represent increasing severity of wrinkling) will be given.
The change in score (value) from the scale before and after the treatment will be calculated.
Measured: 10 months
Secondary outcomes (2)
Safety - Occurence of AE
The occurence of serious AE during the whole study will be followed.
Measured: 10 months
Safety - Therapy comfort
The discomfort during the therapy will be evaluated immediately after every therapy, using the Discomfort Questionnaire. Subjects will be asked to evaluate the agreement with the statement concerning the conformity of the study treatment. Subjects will be evaluating the agreement by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Based on a given answers, the therapy comfort will be calculated.
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 posted6 Jun 2018
- Study start1 Mar 2018
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548025
- Sponsor's protocol ID
- BTL-786-001
- Status last verified
- Jun 2018
- First submitted
- 28 Mar 2018
- Last updated
- 8 Jun 2018
- 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 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles
- ClinicalTrials.gov ID
- NCT03548025
- Acronym / sponsor ID
- BTL-786-001
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 6 Jun 2018 (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.
The study will evaluate safety and effectivity of the BTL-FR2000 device for the treatment of facial wrinkles.
Detailed description
Subjects will be photographed at the baseline visit. After the treatment phase, subjects will be invited for two follow-up visits - 3 and 6 months after the last therapy. They will be again photographed.
Three blinded evaluators will be scoring the full face photos according to the Fitzpatrick Wrinkle Severity Scale. The improvement of the scores will be evaluated. Every subject will serve as its own control.
In addition, the occurence of an AE during the whole study, as well as the therapy discomfort during the treatment phase, will be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: BTL-703 (Treatment group)Treated group of subjects, serves as its own control |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 22 years
- Voluntarily signed informed consent form
Key exclusion criteria (26 listed)
- Bacterial or viral infection, acute inflammations
- Impaired immune system
- Isotretinoin in the past 12 months
- Skin related autoimmune diseases
- Radiation therapy and 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 |
|---|---|---|
| BTL-703 (Treatment group)Treatment with BTL-FR2000 Device | Device | Treatment Group |
Primary outcome
Improvement of facial wrinkles evaluated through the change in the value of the validated scale
Time frame: 10 months
Three blinded evaluators will be evaluating the full-face photographs taken at the baseline, last therapy visit and both follow-up visits. They will be evaluating it using the validated Fitzpatrick Wrinkle Severity Scale. According to that scale, subjects are divided in three categories (I, II, III) corresponding to mild, moderate, and severe wrinkling, and degree of elastosis. In addition, a score of 1 to 9 (a linear sliding scale to represent increasing severity of wrinkling) will be given. The change in score (value) from the scale before and after the treatment will be calculated.
2 secondary outcomes
Safety - Occurence of AE
Time frame: 10 months
Safety - Therapy comfort
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL-703 (Treatment group) 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 2 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 8 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgi Petkov (32 62 22 52 ext. +359, petkov@btlnet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of facial wrinkles evaluated through the change in the value of the validated scale (time frame: 10 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 8 Jun 2018.