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WrinkleNCT05987917

Clinical and Histological Evaluation of BTL-785F Non-invasive Treatment for Facial Rejuvenation

A study testing BTL-785-2 and No Treatment in people with Wrinkle, run by BTL Industries Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-2 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. 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?
BTL-785-2 and No Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
25 Jan 2021to 3 Jan 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 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 with non-invasive radiofrequency and ultrasound treatment for facial rejuvenation
  • 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
  • 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 undergo punch biopsies in the infraauricular area.
  • Agreement to have their photographs taken for the purpose of this clinical investigation.

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 28Show 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 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 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 anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
  • Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
  • Any disease or condition contradicting the skin tissue biopsy
  • Any disease or condition that may compromise the histologic observation at the pathologist discretion

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Schweiger Dermatology PC, Reseach Division

    Hackensack, New Jersey, 07601

Other trials in United States

About this study

This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-2 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity.

Read the detailed description

The changes in the skin tissue related to the levels of hyaluronic acid (HA) will be assessed histologically. The study is a prospective, single-center, three-arm, open-label study. The subjects will be enrolled and assigned into two treatment groups; group A (RF \& USN) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits. Additionally, a Control will be included to verify the treatment outcomes.

At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies of the facial skin for the examination of changes related to HA levels and photographs of the treated area will be taken.

The treatment administration phase in both treatment groups will consist of four (4) treatment visits, delivered 7 - 14 days apart.

Conditions
Wrinkle
Being tested
BTL-785-2, No Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BTL-785-2Device

    Treatment with BTL-785 device (BTL-785-2 applicator) for non-invasive facial rejuvenation

  • No TreatmentOther

    The subject who will serve as control will not be treated with the study device.

Study groups in NCT05987917
Study groupRoleWhat they receive
Group RF+USNExperimentalSubjects will be enrolled for an active treatment with BTL-785F (BTL-785-2 applicator) delivering radiofrequency (RF) and ultrasound (USN) for non-invasive facial rejuvenation
Receives: Device: BTL-785-2
Group RFExperimentalSubjects will be enrolled for an active treatment with BTL-785F (BTL-785-2 applicator) delivering radiofrequency (RF) only for non-invasive facial rejuvenation
Receives: Device: BTL-785-2
ControlExperimentalControl subject will not receive treatment
Receives: Other: No Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Histological examination

    Evaluation of the facial skin tissue to assess the changes related to levels of HA in the biopsies obtained from both treatment groups and control.

    Measured: 5 months

Secondary outcomes (4)

  1. Subject Satisfaction

    The 5-point Likert scale Subject Satisfaction Questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last therapy, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' overall skin and face appearance will vary from "strongly agree" to "strongly disagree".

    Measured: 5 months

  2. Therapy Comfort

    The 5-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain).

    Measured: 5 months

  3. Evaluation of Wrinkle Severity

    Three independent evaluators will evaluate changes of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale (FWES) using the photographs of treated areas for wrinkles (left and right cheeks and the forehead) taken at the baseline, last therapy visit and each follow-up visit. Wrinkle severity improvement according to FWES is considered when there is a decrease in score of the scale. The baseline and post-treatment scores will be compared. If applicable, the statistical significance of obtained results will be analyzed in Microsoft Excel spreadsheet software. The level of significance (α) will be set as 5%.

    Measured: 5 months

  4. Evaluation of Overall Facial Appearance According to GAIS

    Three evaluators will evaluate facial appearance in the treatment group according to the Global Aesthetic Improvement Scale (GAIS) using the photographs taken at the baseline, last therapy visit and both follow-up visits. Each evaluator will be asked to assign a score to a set of photographs. Facial appearance improvement to GAIS is considered when there is an increase in score of the scale. The baseline and post-treatment scores will be compared. If applicable, the statistical significance of obtained results will be analyzed in Microsoft Excel spreadsheet software. The level of significance (α) will be set as 5%.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start25 Jan 2021
  3. Primary completion3 Jan 2022
  4. Study completion3 Jan 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05987917
Sponsor's protocol ID
BTL-785_CTUS300
Status last verified
Aug 2023
First submitted
4 Aug 2023
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Goldberg DJ. A Novel Technology to Boost Natural Production of Hyaluronic Acid in the Skin Tissue: Human Histology Study. J Cosmet Dermatol. 2025 Apr;24(4):e70159. doi: 10.1111/jocd.70159.

    PubMed 40243133

Questions about this trial

What is this clinical trial studying?

A study testing BTL-785-2 and No Treatment in people with Wrinkle, run by BTL Industries Ltd. at 1 site 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 6 inclusion and 28 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 2 Feb 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 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?

Histological examination (time frame: 5 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 NCT05987917, 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 2 Feb 2024.

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