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| Name | Class |
|---|---|
| Medicis Pharmaceutical Corporation | INDUSTRY |
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The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin alone. These two products have been FDA approved to improve the appearance of facial wrinkles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Botulinum Toxin A and Hyaluronic Acid | Experimental | One side of face treated with the combination of Botulinum Toxin A and Hyaluronic Acid injections. |
|
| Botulinum Toxin A alone | Active Comparator | Other side of face treated with =Botulinum Toxin A injection alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination Botulinum Toxin A and Hyaluronic Acid | Procedure | One side of subject's face will randomly be assigned combination treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure: | Two blinded dermatologists will rate each photograph of each subject at baseline, week 2, month 3, and month 6. The raters will provide a glabellar wrinkle score and a forehead wrinkle score for each photograph. The raters will not know what treatments the subjects received or at what point in time the photographs were taken. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Percent Improvement |
|
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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 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
Has prior history of nodule formation or hypersensitivity reactions to lidocaine or hyaluronic acid derivatives
Is currently using anticoagulation therapy
Has a history of bleeding disorders
Is unable to understand the protocol or to give informed consent
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 |
|---|---|---|---|---|---|---|
| Alejandra Onate | Chicago | Illinois | 60611 | United States |
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| Botulinum Toxin A | Procedure | Other side of subjects face with receive Botulinum Toxin A treatment alone. |
|
| 1 year |
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| 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 |
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