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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03548025
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
BTL Industries Ltd.

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

Condition or disease Intervention/treatment Phase
Wrinkle Device: BTL-703 (Treatment group) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 1, 2019

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




Primary Outcome Measures :
  1. Improvement of facial wrinkles evaluated through the change in the value of the validated scale [ Time Frame: 10 months ]

    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.



Secondary Outcome Measures :
  1. Safety - Occurence of AE [ Time Frame: 10 months ]
    The occurence of serious AE during the whole study will be followed.

  2. Safety - Therapy comfort [ Time Frame: 4 months ]
    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.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548025


Contacts
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Contact: Georgi Petkov 32 62 22 52 ext +359 petkov@btlnet.com

Locations
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Bulgaria
Aesthe Clinic Recruiting
Sofia, Bulgaria
Contact: Radina Denkova, MD       aestheclinic@abv.bg   
Sponsors and Collaborators
BTL Industries Ltd.

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Responsible Party: BTL Industries Ltd.
ClinicalTrials.gov Identifier: NCT03548025     History of Changes
Other Study ID Numbers: BTL-786-001
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No