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

NCT ID: NCT03548025

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-03-01

Brief Summary

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

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.

Conditions

Wrinkle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Treated group of subjects, serves as its own control

Group Type: EXPERIMENTAL

BTL-703 (Treatment group)

Intervention Type: DEVICE

Treatment with BTL-FR2000 Device

Interventions

BTL-703 (Treatment group)

Treatment with BTL-FR2000 Device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BTL Industries Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aesthe Clinic

Sofia, , Bulgaria

Site Status: RECRUITING

Countries

Bulgaria

Central Contacts

Georgi Petkov

Role: CONTACT

petkov@btlnet.com

32 62 22 52 ext. +359

Facility Contacts

Radina Denkova, MD

Role: primary

aestheclinic@abv.bg

Other Identifiers

BTL-786-001

Identifier Type: -

Identifier Source: org_study_id