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Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imipramine and Vehicle | Experimental | 4% imipramine and vehicle are applied on a 2x2cm2 area of the subject's cheek. The imipramine is applied on one side of the subject's face (cheek) and vehicle is applied on the other side. |
|
| Amitriptyline and Vehicle | Experimental | 4% amitriptyline and vehicle are applied on a 2x2cm2 area of the subject's cheek. The amitriptyline is applied on side of the subject's face (cheek) and vehicle is applied on the other side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imipramine | Drug | 4% imipramine |
| |
| Amitriptyline |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in redness of Ultraviolet B induced erythema with 4% imipramine | Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography. | 10 minutes post-treatment |
| Difference in redness of Ultraviolet B induced erythema with 4% imipramine | Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography. | 60 minutes post-treatment |
| Difference in redness of Ultraviolet B induced erythema with 4% imipramine | Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography. | 120 minutes post-treatment |
| Difference in redness of Ultraviolet B induced erythema with 4% imipramine | Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography. | 24 hours post-treatment |
| Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline | Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography. | 10 minutes post-treatment |
| Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline | Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of 4% imipramine on facial skin | The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch] | 10 minutes post-treatment |
| Tolerability of 4% imipramine on facial skin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manager Clinical Research Operations | Contact | (937)-245-7500 | pturesearch@wrightstatephysicians.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright State Physicians | Recruiting | Fairborn | Ohio | 45324 | United States |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007099 | Imipramine |
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
4% amitriptyline |
|
| Vehicle | Drug | 0.1ml propylene glycol |
|
| 60 minutes post-treatment |
| Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline | Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography. | 120 minutes post-treatment |
| Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline | Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography. | 24 hours post-treatment |
The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch] |
| 60 minutes post-treatment |
| Tolerability of 4% imipramine on facial skin | The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch] | 120 minutes post-treatment |
| Tolerability of 4% imipramine on facial skin | The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch] | 24 hours post-treatment |
| Tolerability of 4% amitriptyline on facial skin | The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch] | 10 minutes post-treatment |
| Tolerability of 4% amitriptyline on facial skin | The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch] | 60 minutes post-treatment |
| Tolerability of 4% amitriptyline on facial skin | The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch] | 120 minutes post-treatment |
| Tolerability of 4% amitriptyline on facial skin | The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch] | 24 hours post-treatment |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |