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This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive treatment of facial wrinkles.
The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.
At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.
Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups. Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTL-785-7 Treatment | Experimental | Treatment of wrinkles with the BTL-785-7 applicator to the BTL-785F system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-785-7 | Device | Treatment with the BTL-785-7 applicator to the BTL-785F system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Noninvasive Treatment Of Wrinkles | Assess change in wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. Baseline and post-treatment photographs will be evaluated. A statistically significant decrease of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale should be achieved. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Quality Assessment | Three evaluators will evaluate facial appearance according to the Global Aesthetic Improvement Scale (GAIS) using the photographs taken at the baseline, last therapy visit and both follow-up visits. Each evaluator will be asked to assign a score to a set of photographs. Facial appearance improvement to GAIS is considered when there is an increase in score of the scale. The baseline and post-treatment scores will be compared. If applicable, the statistical significance of obtained results will be analyzed in Microsoft Excel spreadsheet software. The level of significance (α) will be set as 5%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contour Medical | Gilbert | Arizona | 85297 | United States | ||
| Holden Timeless Beauty |
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| 5 months |
| Therapy Comfort | The 5-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain). | 5 months |
| Subject Satisfaction | The Subject Satisfaction questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last treatment, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' overall skin and face appearance will vary from "strongly agree" to "strongly disagree". | 5 months |
| San Marcos |
| California |
| 92069 |
| United States |
| Precision Skin Institute | Davie | Florida | 33328 | United States |
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | United States |
| Jennifer Levine MD | New York | New York | 10075 | United States |