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

Last updated: January 24, 2025
Sponsor: Wright State University
Overall Status: Active - Recruiting

Phase

1

Condition

Sun Poisoning

Rosacea

Treatment

4% Imipramine Cream

Base Cream

Clinical Study ID

NCT04520217
06919
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 beallowed to be taking a medication that is known to be photosensitizer.

Exclusion

Exclusion Criteria:

  • Underlying diseases that could affect wound healing (e.g., uncontrolled diabetesmellitus)

  • Taking medications that are known photosensitizers (e.g., doxycycline) oranti-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

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: 4% Imipramine Cream
Phase: 1
Study Start date:
June 06, 2022
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Active - Recruiting

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