Pilot Studies 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).

Criteria:

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 is Available At:

Original ID:

06919

NCT ID:

NCT04520217

Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

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

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT04520217

Overall Status:

Recruiting

Study Phase:

Phase 1

Genders:

N/A

Minimum Age:

18 Years

Maximum Age:

50 Years

Study Source:

Wright State University

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Number of Arms:

1

Number of Groups:

0

Total Enrollment:

40

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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