WrinkleNCT06158438
Safety and Efficacy of the BTL-754 Device for Laser Skin Resurfacing Treatment of the Face
A study testing BTL-754-4 Treatment 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-754 device (equipped with the 754-4 applicator) for reduction of facial wrinkles by the means of laser skin resurfacing treatment. 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-754-4 Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBulgaria
- Study dates
- 16 Nov 2023to 19 Aug 2024
- 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
- Healthy male or female subjects over 22 years of age seeking treatment for reduction of wrinkles.
- Presence of clearly visible wrinkles in the treated area when the face is relaxed as deemed appropriate by the Investigator.
- Subjects are willing to have polycarbonate eye shields placed for study treatment.
- Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form.
- Subjects are willing to maintain the usual skin care regimen during study participation with the exception when protocol specified ointments, moisturizers, and cleansers are required during the healing stage. Sunblock is required throughout the subject's participation in the study.
- Subjects are willing to abstain from other facial cosmetic procedures during the study; examples include, but are not limited to: laser or chemical resurfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial surgery, etc.
- Subjects are willing and able to comply with protocol requirements, including obtaining study-required digital photographs and assessments, post-care instructions, and returning for follow-up visits.
- Women of childbearing potential are required to use birth control measures.
Who cannot join
- Intolerance to anesthetic based agents
- Infectious disease
- Connective tissue disease
- Propensity for keloid formations
- Immunocompromised or compromised healing
- Use of long-standing systemic steroids (e.g. Prednisone, Dexamethasone)
Show all 27Show fewer
- Pregnant, planning to become pregnant, or breast feeding during the study
- Use of isotretinoin (e.g. Accutane, Sotret, Claravis, Amnesteem) within the past year
- Medical condition that may affect wound healing
- Any unstable medical or psychiatric conditions
- Major systemic diseases - e.g. uncontrolled Diabetes mellitus
- Photosensitivity, medications affecting sensitivity to light
- Corticosteroids or injections of the treated area within the last 90 days, long-term corticosteroids use
- Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
- Blepharoplasty (in case of eyelid treatment)
- Anticoagulant therapy, bleeding disorders
- Application within 4 to 6 months after radiotherapy
- Known or suspected malignancy, history of cancer or any type of malignancy
- Febrile conditions, serious illness, chronic infection
- Epilepsy
- Deep vein thrombosis
- Subject has had concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety and effectiveness of the study treatment method.
- Subject is enrolled in another investigational (drug or device) clinical trial or has participated in any other investigational study within 30 days prior to consent that can interfere with this study's assessments as per investigator's discretion.
- Subject has undergone a facelift procedure, IPL, laser, microneedling, chemical peels, dermal fillers, BOTOX® or other toxins within 6 months prior to the screening visit.
- Tattoo(s) or permanent make-up in the intended treatment area.
- Subject has used, within 30 days prior to screening or plans to use during study participation, Accutane, Retinol, or any medication that can cause dermal hypersensitivity.
- Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Center for specialized medical care - Individual dermatological practice Dr. Mariya Genova
Plovdiv, Plovdiv, 4000
About this study
This study will evaluate the clinical safety and the performance of the BTL-754 device (equipped with the 754-4 applicator) for reduction of facial wrinkles by the means of laser skin resurfacing treatment.
- Conditions
- Wrinkle
- Being tested
- BTL-754-4 Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-754-4 TreatmentDevice
Treatment with the BTL-754 device with the BTL-754-4 applicator for reduction of facial wrinkles.
| Study group | Role | What they receive |
|---|---|---|
| BTL-754-4 Treatment | Experimental | Treatment with BTL-754 device with the applicator BTL-754-4 for reduction of facial wrinkles. Receives: Device: BTL-754-4 Treatment |
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
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: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start16 Nov 2023
- Primary completion7 Jun 2024
- Study completion19 Aug 2024
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
- 56 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
- NCT06158438
- Sponsor's protocol ID
- BTL-754_CTBG100
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2023
- Last updated
- 14 Nov 2024
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the BTL-754 Device for Laser Skin Resurfacing Treatment of the Face
- ClinicalTrials.gov ID
- NCT06158438
- Acronym / sponsor ID
- BTL-754_CTBG100
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 6 Dec 2023 (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-754 device (equipped with the 754-4 applicator) for reduction of facial wrinkles by the means of laser skin resurfacing 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-754-4 Treatment | Experimental | Device: BTL-754-4 TreatmentTreatment with BTL-754 device with the applicator BTL-754-4 for reduction of facial wrinkles. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male or female subjects over 22 years of age seeking treatment for reduction of wrinkles.
- Presence of clearly visible wrinkles in the treated area when the face is relaxed as deemed appropriate by the Investigator.
- Subjects are willing to have polycarbonate eye shields placed for study treatment.
- Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form.
- Subjects are willing to maintain the usual skin care regimen during study participation with the exception when protocol specified ointments, moisturizers, and cleansers are required during the healing stage. Sunblock is required throughout the subject's participation in the study.
Key exclusion criteria (27 listed)
- Intolerance to anesthetic based agents
- Infectious disease
- Connective tissue disease
- Propensity for keloid formations
- Immunocompromised or compromised healing
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-754-4 TreatmentTreatment with the BTL-754 device with the BTL-754-4 applicator for reduction of facial wrinkles. | Device | BTL-754-4 Treatment |
Primary outcome
Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale
Time frame: 5 months
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.
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 14 Nov 2024.
- 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.
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-754-4 Treatment 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 8 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 14 Nov 2024. 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: 5 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 14 Nov 2024.