Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will evaluate safety and effectivity of the BTL-FR2000 device for the treatment of facial wrinkles.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Treated group of subjects, serves as its own control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-703 (Treatment group) | Device | Treatment with BTL-FR2000 Device |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgi Petkov | Contact | 32 62 22 52 | +359 | petkov@btlnet.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthe Clinic | Recruiting | Sofia | Bulgaria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 4 months |