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

Wright State University

Status and phase: Enrolling; Phase 1

Conditions: Microvesicle Particle; Photosensitivity

Treatments: Drug: 4% Imipramine Cream; Drug: Base Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04520217

06919

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

4% Imipramine Cream on UVB-Treated Areas

Experimental group

Description:

* 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

Treatment:

Drug: Base Cream

Drug: 4% Imipramine Cream