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| Name | Class |
|---|---|
| DeNova Research | OTHER |
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This is an open-label, single-center, randomized, split-face, controlled study to assess the effect of comfort intervention on pain during treatment injection compared against non-comfort intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Subjects will be treated for correction of glabellar lines with Dysport and comfort intervention on one side and Dysport only on the other side depending on pre-determined randomization. Subjects will complete the study assessments and end the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrating Beauty Bar | Device | A vibrating beauty bar will be used at the injection site for patient comfort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | Visual Analogue Scale is a 11-point psychometric scale that specifies the level of pain. Subject will be shown a photo of a VAS and verbally report a pain score between 0 and 10, which will be captured by a clinic staff. A score of 0 corresponds to no pain felt and a score of 10 corresponds to very high pain. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Self-assessment questionnaire | To evaluate investigator and subject's satisfaction and preference on treatment experience using self-assessment questionnaires on treatment injection with and without comfort intervention | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant, breastfeeding, or planning pregnancy during the course of the study, confirmed by UPT.
Current smokers or consumer nicotine (e.g., cigarettes, e-cigarettes, vaping device with pre-filled pods, vapor tank or mod, chewing tobacco)
History of allergy or hypersensitivity to botulinum toxin type A, human albumin, lactose, or cow's milk protein
Subject with signs and symptoms of eyelid or brow ptosis, inability to substantially lessen glabellar lines by physically spreading them apart, or history or presence of facial nerve palsy, as judged by the Investigator.
Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
Previous aesthetic treatment in the face with any of the following injection prior to the baseline visit:
Previous treatment/procedure in the face in the previous 2-4 weeks that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study e.g.,
Presence of any disease or lesions near or on the glabellar region, e.g.,
History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation (e.g., aspirin or other non-steroidal anti-inflammatory drugs), omega 3, or vitamin E within 14 days before treatment. Omega 3 and vitamin E are acceptable only as part of a standard multivitamin formulation.
Planning on having surgeries and/or invasive medical procedures during the course of the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova Research | Chicago | Illinois | 60611 | United States |
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Subjects will receive comfort intervention on one side of face, and will not receive comfort intervention on the other side of face.
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