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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. Occurence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTL-785-7 Treatment | Experimental | Treatment with the BTL-785-7 applicator to the BTL-785F system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-785-7 Treatment | Device | Treatment of wrinkles with the BTL-785-7 applicator to the BTL-785F system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Noninvasive Treatment Of Wrinkles | Assess changes in wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. Baseline and post-treatment photographs will be evaluated. A statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale should be achieved. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of skin quality and aesthetic changes of the treated areas after the therapies | Evaluation of skin quality and aesthetic changes of the treated areas after the therapies based on photographs before and after the study procedure according to the Global Aesthetic Improvement Scale. | 4 months |
| Subject Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AboutSkin Research, LLC | Greenwood Village | Colorado | 80111 | United States | ||
| Skin and Allergy Center |
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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". |
| 4 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). | 4 months |
| Spring Hill |
| Tennessee |
| 37174 |
| United States |