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The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.
Subjects will be screened, photographed, assessed, and randomized to be injected with onabotulinum toxin A on one side and incobotulinum toxin A on the other side during their first clinic visit. Subjects will return for a 2 week, 2 month, 3 month, 4 month, 5 month, and 6 month follow-up to have photographs taken by the unblinded research assistant at relaxed and full contraction.
This study is a pilot study designed to determine feasibility of these procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Onabotulinum Toxin A | Active Comparator | One side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face. |
|
| Incobotulinum Toxin A | Active Comparator | The other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onabotulinum Toxin A | Drug |
|
| |
| Incobotulinum Toxin A |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin | Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The glabellar wrinkle rating is: 0: no facial wrinkles
| At baseline and at 6 months |
| Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin | Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The forehead wrinkle Merz rating is: 0: no wrinkles
| At baseline and at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating
Younger than 20 or older than 65 years of age
Has received the following treatments in the forehead or glabellar region:
Is planning to receive within the next 6 months, 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 6 months
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
Has a mental illness
Unable to understand the protocol or to give informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| C000629279 | onabotulinum toxin A |
| D019274 | Botulinum Toxins, Type A |
| C545476 | incobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Drug |
|
|
| 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 |