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This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.
In this cross-over design study, the investigators will evaluate whether active muscle contraction following Botox® injection of the forehead/glabellar rhytid complex will impact the onset of action, efficacy, and duration of Botox® treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Muscle contractions | Experimental | Under supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits. |
|
| No muscle contractions | Active Comparator | Patients will be asked to not perform muscle contractions following Botox injections. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin A | Procedure | Forehead will be injected with Botox. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale | A single dermatologist will rate each photograph of the subject's forehead/glabellar rhytid complex at baseline, 1 day, 2 days, 3 days, 4 days, 7 days, 2 weeks, 7 months and 1 day, 7 months and 2 days, 7 months and 3 days, 7 months and 4 days, 7 months and 7 days, and 7 months and 2 weeks. A glabellar wrinkle score and a forehead wrinkle score will be assigned to each photograph. The dermatologist will not know at what point in time the photographs were taken. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Side effects and adverse events will be assessed | 13 months |
| Level of Satisfaction | Patients will be asked to rate their satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating
Has received the following treatments in the forehead or glabellar region:
Is planning to receive within the next year, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
Is planning to use tretinoin or retinoic acid in the next year
Has an active infection in the forehead or glabellar region (excluding mild acne)
Is allergic to cow's-milk protein
Is allergic to albumin
Taking aminoglycoside
Is currently using anticoagulation therapy
Has a history of bleeding disorders
Is unable to understand the protocol or to give informed consent
Is unable to return for follow-up visits
Has a mental illness
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 7 months |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |