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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.