Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects

Study Overview
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Brief Summary
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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).

Official Title
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Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects

Conditions
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Photosensitivity, Microvesicle Particle

Intervention / Treatment
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* Drug: 4% Imipramine Cream
* Drug: Base Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and Male adult subjects age 18 to 50 Must be able to give informed consent Have access to stable transportation All skin types on Fitzpatrick Scale (Type I-VI) Self-Identified photosensitivity Able to provide medical history and list of medications-control subjects will not be allowed to be taking a medication that is known to be photosensitizer. Exclusion Criteria: Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus) Taking medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids) Utilizing imipramine or any other tricyclic antidepressant (oral or cream) Utilizing topical anti-inflammatory or systemic agents (e.g., prednisone) Large tattoos in the designated testing areas Tanning bed use within last 3 months Photodynamic Therapy or UVB treatments in past 3 months Female Subjects: pregnant or nursing History of abnormal scarring (i.e., keloids)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4% Imipramine Cream on UVB-Treated Areas<br>2g of 4% imipramine cream will be applied to the UVB-treated areas on volar forearm and back. 2g of base cream will be applied to the UVB-treated areas on volar forearm and back. No cream will be applied to a UVB-treated area on the back | Drug: 4% Imipramine Cream<br>* 4% Imipramine Cream<br>Drug: Base Cream<br>* Base Cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |