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| Name | Class |
|---|---|
| Daniel Alain, Inc. | INDUSTRY |
| Follea International Limited | INDUSTRY |
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Pharmacokinetic Study of DA-020
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of DA-020
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-020 (0.1%) | Experimental | Topical Oxymetazoline 0.1% - 7mL |
|
| DA-020 (0.2%) | Experimental | Topical Oxymetazoline 0.2% - 7mL |
|
| DA-020 (0.5%) | Experimental | Topical Oxymetazoline 0.5% - 7mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-020 (0.1%) | Drug | DA-020 (0.1%) |
| |
| DA-020 (0.2%) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of DA-020 in Serum | Determine the amount of Oxymetazoline in serum after 1 time scalp application | Hours [0, 1, 2, 4, 8, 12, 24] |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of DA-020 | Determine blood pressure following a single application of DA-020 | Hours [0, 1, 2, 4, 8, 12, 24] |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andy Goren, MD | Contact | 16507040850 | clinicalstudies@appliedbiology.com |
| Name | Affiliation | Role |
|---|---|---|
| Andy Goren, MD | University of Rome G. Marconi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Samel | Manaus | Brazil |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27704205 | Background | Fahl WE. Complete prevention of radiation-induced dermatitis using topical adrenergic vasoconstrictors. Arch Dermatol Res. 2016 Dec;308(10):751-757. doi: 10.1007/s00403-016-1691-2. Epub 2016 Oct 4. | |
| 24811525 | Background | Soref CM, Fahl WE. A new strategy to prevent chemotherapy and radiotherapy-induced alopecia using topically applied vasoconstrictor. Int J Cancer. 2015 Jan 1;136(1):195-203. doi: 10.1002/ijc.28961. Epub 2014 May 16. |
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| Drug |
DA-020 (0.2%) |
|
| DA-020 (0.5%) | Drug | DA-020 (0.5%) |
|
| University of Rome ("G. Marconi") | Rome | Italy |
|