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NCT04520217PHASE1RecruitingAccepts Healthy Volunteers

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

Wright State University

Start Date

6/6/2022

Completion Date

12/1/2026

Summary

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).

Eligibility Criteria

Age Range: 18 years to 50 years

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)

Interventions

DRUG

4% Imipramine Cream

DRUG

Base Cream

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Conditions

PhotosensitivityMicrovesicle Particle

Locations

Wright State Physicians

Fairborn, Ohio 45324

United States