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RecruitingPhase 1NCT04520217

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

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

Sponsor

Wright State University

Enrollment

40 participants

Start Date

Jun 6, 2022

Study Type

INTERVENTIONAL

Conditions

PhotosensitivityMicrovesicle Particle

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

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria6

  • 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 Criteria9

  • 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)

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Interventions

DRUG4% Imipramine Cream

4% Imipramine Cream

DRUGBase Cream

Base Cream

Locations(1)

Wright State Physicians

Fairborn, Ohio, United States

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NCT04520217