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This study will evaluate the clinical safety and the efficacy of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive facial treatment in patients injected with botulinum toxin. The aim is to investigate the improvement of overall facial appearance and muscle tone.
This study is a single-site, open-label, interventional study. The subjects will be enrolled and assigned into two experimental study arms (active and control group).
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 (only for the active group) 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 (the control group will not receive any treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTL-785-7 Treatment | Experimental | Subjects will be enrolled for an active treatment with BTL-785F device (BTL-785-7 applicator) for improvement of overall facial appearance and muscle tone in patients injected with botulinum toxin. |
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| Control | No Intervention | Two (2) patients will be enrolled in the control group study and will not receive any treatment. Following the completion of the investigation, the control group patients will be offered the same treatment course as the active group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-785-7 Treatment | Device | Treatment with BTL-785F device (BTL-785-7 applicator) for improvement of overall facial appearance and muscle tone in patients injected with botulinum toxin. |
| Measure | Description | Time Frame |
|---|---|---|
| Facial Appearance Change | 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. The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better. 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%. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Facial expression assessment | Short facial expression records will be taken for evaluating the level of change in the facial expression. The patients will be required to perform happy, angry, and surprised expressions. The video of patients facial expressions will be taken at baseline, after the treatment, and at all follow-up visits. These records will be also evaluated with GAIS scoring. The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Refresh Dermatology | Houston | Texas | 77081 | United States |
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| 5 months |
| Therapy Comfort | The 7-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 7-point Likert scale Subject Satisfaction Questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last therapy, 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 |