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
|Condition or disease||Intervention/treatment||Phase|
|Wrinkle||Device: BTL-703 (Treatment group)||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Treatment Group
Treated group of subjects, serves as its own control
Device: BTL-703 (Treatment group)
Treatment with BTL-FR2000 Device
- 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.
- 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.
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
|Contact: Georgi Petkov||32 62 22 52 ext +firstname.lastname@example.org|
|Contact: Radina Denkova, MD email@example.com|