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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03548025
Recruitment Status : Unknown
Verified June 2018 by BTL Industries Ltd..
Recruitment status was:  Recruiting
First Posted : June 6, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
BTL Industries Ltd.

Tracking Information
First Submitted Date  ICMJE March 28, 2018
First Posted Date  ICMJE June 6, 2018
Last Update Posted Date June 8, 2018
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
  • Safety - Occurence of AE [ Time Frame: 10 months ]
    The occurence of serious AE during the whole study will be followed.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Safety - Occurence of AE [ Time Frame: 10 months ]
    The occurence of serious AE during the whole study will be followed.
  • Safety - Therapy comfort [ Time Frame: 4 months ]
    The discomfort during the therapy will be evaluated immediately after every therapy, using the Discomfort Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles
Official Title  ICMJE Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wrinkle
Intervention  ICMJE Device: BTL-703 (Treatment group)
Treatment with BTL-FR2000 Device
Study Arms  ICMJE Experimental: Treatment Group
Treated group of subjects, serves as its own control
Intervention: Device: BTL-703 (Treatment group)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2019
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548025
Other Study ID Numbers  ICMJE BTL-786-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BTL Industries Ltd.
Study Sponsor  ICMJE BTL Industries Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BTL Industries Ltd.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP