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NCT Number: NCT04520217

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

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).

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Key information

Conditions

Photosensitivity Microvesicle Particle Photosensitivity Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

4% Imipramine Cream

Drug

4% Imipramine Cream

Base Cream

Drug

Base Cream

Primary outcomes

  1. Change in microvesicle particle levels from baseline in clinically photosensitive subjects

    Time frame: 4 Hours

    This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.

  2. Change in microvesicle particle levels from baseline post topical imipramine application

    Time frame: 4 Hours

    This will be measured in skin biopsies with topical imipramine applied. Biopsies are obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.

  3. Change in skin erythema from baseline on topical imipramine treated skin

    Time frame: 4 Hours

    This will be measured with a mexameter at 4 hours.

  4. Change in skin erythema from baseline on topical imipramine treated skin

    Time frame: 24 Hours

    This will be measured with a mexameter at 24 hours.

Study contacts

Contact information is provided by the study sponsor or research team.

Manager Clinical Research Operations

CONTACT

[email protected]

937-245-7500

Regulatory Specialist

CONTACT

[email protected]

937-245-7500

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2020
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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