Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles

NCT04447963 | Completed

• 1 other identifier: BTL-785F_WRI
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Assess safety profile by recording of adverse events

  7 months

• Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire

  6 months

Study Arms (1)

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.

Device: Non-invasive treatment of facial wrinkles

Interventions

Non-invasive treatment of facial wrinkles DEVICE

Application of radiofrequency field which provides controlled heating to the skin.Therapeutic effect is observed when the tissue temperature reaches 40-45 degrees Celsius.

Non-invasive treatment of wrinkles and rhytids

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Dermatological center "Lege Artis"

Stara Zagora, Bulgaria

Location

Study Officials

• Evgeni Hristozov, MD

  Dermatologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: June 15, 2020
• Primary Completion: March 31, 2021
• Study Completion: June 28, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)