Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles

The study will evaluate safety and effectivity of the BTL-FR2000 device for the treatment of facial wrinkles.

Study Overview

• Status: Unknown
• Conditions: Wrinkle
• Intervention / Treatment: Device: BTL-703 (Treatment group)

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Recruiting
    • Aesthe Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 22 years
• Voluntarily signed informed consent form

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Treated group of subjects, serves as its own control	Device: BTL-703 (Treatment group); Treatment with BTL-FR2000 Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Occurence of AE	The occurence of serious AE during the whole study will be followed.	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.	4 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: BTL-786-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No