WrinkleNCT06645366
Device for Improving Skin Quality and Texture on the Face and Neck
A study testing Treatment with BTL-785F in people with Wrinkle and Pigmentation, run by BTL Industries Ltd. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Pigmentation, Skin Laxity
- What is being tested?
- Treatment with BTL-785F
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jun 2024to 29 Apr 2025
- 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 30 years of age seeking treatment for improvement in skin quality and texture on 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
- Subjects willing and able to abstain from partaking in any facial or neck 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 and neck without makeup 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 medication
- 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 near the treatment area or neutral electrode
- Permanent implant in the treated area
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
- 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)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
- Tuberculosis
- Hepatitis
- Febrile conditions
- 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
- History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
- Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks
- Neurotoxin/collagen/fat injections or other injected bio-material in the treated area within three months prior to the treatment
- Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session
- Treating over tattoo or permanent make-up
- Treating over eyelids or the lips
- Patients with allergy to anesthetics
- Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
- Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boyd Beauty
Birmingham, Michigan, 48009
Capital Laser & Skin Care
Chevy Chase, Maryland, 20815
AboutSkin Dermatology & DermSurgery
Greenwood Village, Colorado, 80111
About this study
Official title: Evaluation of Safety and Efficacy of the BTL-785F Device for Improvement in Skin Quality and Texture on Face and Neck
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.
Read the detailed description
This study will evaluate the safety and efficacy of the BTL-785F system equipped with the BTL-785-4-4 tip on BTL-785-4 applicator for the improvement of skin quality and texture on the face and neck. It is a prospective, multi-center, open label, one-arm study.
Subjects will be required to complete three (3) treatment visits and two (2) follow-up visits (at 1 month, 3 months post-treatment).
At baseline, inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient. 2D and 3D photographs of the subjects will be taken.
The treatment administration phase consists of three (3) treatment visits, delivered 2 - 6 weeks apart, after the complete healing of scabs. Before the second and third treatment, 2D and 3D photographs will be taken. After each treatment, subjects will be asked to fill in the Therapy Comfort Questionnaire for the assessement of subjects' comfort during the treatments. After the last treament, subjects will receive Subject Satisfaction Questionnaire to record subjects' satisfaction with the treatment results.
At both follow-up visits, subjects will receive Subject Satisfaction Questionnaire to fill in, and 2D and 3D photographs will be taken.
Safety measures will include documentation of adverse events (AE) during and after the treatment procedures and at the follow-up visits, and if needed medical assistance.
- Conditions
- Wrinkle, Pigmentation, Skin Laxity, Skin Scarring
- Being tested
- Treatment with BTL-785F
- Keywords
- skin, texture, wrinkles, skin quality
- Medical subject headings
- Cutis Laxa, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-785FDevice
Three (3) treatment sessions will be applied to the subjects' face and neck using the BTL-785F system equipped with the BTL-785-4-4 tip on BTL-785-4 applicator, lasting from 20 to 60 minutes depending on the size of the treated area. Each treatment will be spaced 2 - 6 weeks apart, after the complete healing of scabs.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BTL-785F | Experimental | Three (3) treatment sessions will be applied to the subjects' face and neck using the BTL-785F system. Receives: Device: Treatment with BTL-785F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Quality Improvement Assessment
The primary efficacy outcome measure is aesthetic improvement 3 months post-treatment, assessed using 2D photographs on the Global Aesthetic Improvement Scale (GAIS), as well as the degree of clinical improvement determined by automated analysis of 3D photographs using the 3D analysis device's software. Improvement is considered an increase in the GAIS score, as well as in the score determined by the 3D analysis device's software.
Measured: 12 months
Secondary outcomes (3)
Incidence of Treatment-related Adverse Events
To evaluate the safety of the BTL-785F device with the BTL-785-4-4 tip on the BTL-785-4 applicator for the improvement of skin quality and texture through monitoring of adverse reactions.
Measured: 12 months
Satisfaction Assessed by the Subject Satisfaction Questionnaire
The 5-point Likert scale Subject Satisfaction Questionnaire will be used for the evaluation of satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last treatment, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' skin quality and overall facial appearance will vary from "strongly agree" to "strongly disagree".
Measured: 12 months
Comfort Assessed by Therapy Comfort Questionnaire
The 5-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be given to subjects after each treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start24 Jun 2024
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
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
- 39 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
- NCT06645366
- Sponsor's protocol ID
- BTL-785_CTUS1700
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. 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 Improvement in Skin Quality and Texture on Face and Neck
- ClinicalTrials.gov ID
- NCT06645366
- Acronym / sponsor ID
- BTL-785_CTUS1700
- Conditions
- Wrinkle, Pigmentation, Skin Laxity, Skin Scarring
- Keywords
- skin, texture, wrinkles, skin quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 16 Oct 2024 (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 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.
Detailed description
This study will evaluate the safety and efficacy of the BTL-785F system equipped with the BTL-785-4-4 tip on BTL-785-4 applicator for the improvement of skin quality and texture on the face and neck. It is a prospective, multi-center, open label, one-arm study.
Subjects will be required to complete three (3) treatment visits and two (2) follow-up visits (at 1 month, 3 months post-treatment).
At baseline, inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient. 2D and 3D photographs of the subjects will be taken.
The treatment administration phase consists of three (3) treatment visits, delivered 2 - 6 weeks apart, after the complete healing of scabs. Before the second and third treatment, 2D and 3D photographs will be taken. After each treatment, subjects will be asked to fill in the Therapy Comfort Questionnaire for the assessement of subjects' comfort during the treatments. After the last treament, subjects will receive Subject Satisfaction Questionnaire to record subjects' satisfaction with the treatment results.
At both follow-up visits, subjects will receive Subject Satisfaction Questionnaire to fill in, and 2D and 3D photographs will be taken.
Safety measures will include documentation of adverse events (AE) during and after the treatment procedures and at the follow-up visits, and if needed medical assistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-785F | Experimental | Device: Treatment with BTL-785FThree (3) treatment sessions will be applied to the subjects' face and neck using the BTL-785F system. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects over 30 years of age seeking treatment for improvement in skin quality and texture on 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
- Subjects willing and able to abstain from partaking in any facial or neck 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 and neck without makeup 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 medication
- 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 |
|---|---|---|
| Treatment with BTL-785FThree (3) treatment sessions will be applied to the subjects' face and neck using the BTL-785F system equipped with the BTL-785-4-4 tip on BTL-785-4 applicator, lasting from 20 to 60 minutes depending on the size of the treated area. Each treatment will be spaced 2 - 6 weeks apart, after the complete healing of scabs. | Device | Treatment with BTL-785F |
Primary outcome
Skin Quality Improvement Assessment
Time frame: 12 months
The primary efficacy outcome measure is aesthetic improvement 3 months post-treatment, assessed using 2D photographs on the Global Aesthetic Improvement Scale (GAIS), as well as the degree of clinical improvement determined by automated analysis of 3D photographs using the 3D analysis device's software. Improvement is considered an increase in the GAIS score, as well as in the score determined by the 3D analysis device's software.
3 secondary outcomes
Incidence of Treatment-related Adverse Events
Time frame: 12 months
Satisfaction Assessed by the Subject Satisfaction Questionnaire
Time frame: 12 months
Comfort Assessed by Therapy Comfort Questionnaire
Time frame: 12 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 16 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with BTL-785F in people with Wrinkle and Pigmentation, run by BTL Industries Ltd. at 3 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 4 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Skin Quality Improvement Assessment (time frame: 12 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 16 Sep 2025.