Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Second, researchers will assess if topical application of the medicine imipramine will block UVB-induced MVP release. Third, researchers will assess if the topical cream will block UVB-induced increased erythema reactions (reddening of the skin).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4% Imipramine Cream on UVB-Treated Areas | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% Imipramine Cream | Drug | 4% Imipramine Cream |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microvesicle particle levels from baseline in clinically photosensitive subjects | This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2. | 4 Hours |
| Change in microvesicle particle levels from baseline post topical imipramine application | This will be measured in skin biopsies with topical imipramine applied. Biopsies are obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2. | 4 Hours |
| Change in skin erythema from baseline on topical imipramine treated skin | This will be measured with a mexameter at 4 hours. | 4 Hours |
| Change in skin erythema from baseline on topical imipramine treated skin | This will be measured with a mexameter at 24 hours. | 24 Hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manager Clinical Research Operations | Contact | 937-245-7500 | pturesearch@wrightstatephysicians.org | |
| Regulatory Specialist | Contact | 937-245-7500 | pturesearch@wrightstatephysicians.org |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey B Travers, MD, PhD | Wright State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright State Physicians | Recruiting | Fairborn | Ohio | 45324 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2022 | Feb 20, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Base Cream |
| Drug |
Base Cream |
|