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

Purpose

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).

Conditions

  • Photosensitivity
  • Microvesicle Particle

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
4% Imipramine Cream on UVB-Treated Areas 		- 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
    4% Imipramine Cream
  • Drug: Base Cream
    Base Cream

Recruiting Locations

Wright State Physicians
Fairborn 4511263, Ohio 5165418 45324

More Details

Status
Recruiting
Sponsor
Wright State University

Study Contact

Manager Clinical Research Operations
937-245-7500
pturesearch@wrightstatephysicians.org