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

Photosensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04520217
• Other study ID #: 06919
• Status: Recruiting
• Phase: Phase 1
• Start date: June 6, 2022
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Wright State University
• Contact: Manager Clinical Research Operations
• Phone: 937-245-7500
• Email: pturesearch[@]wrightstatephysicians.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Microvesicle Particle
• Photosensitivity

Intervention

Drug:
• 4% Imipramine Cream
4% Imipramine Cream
• Base Cream
Base Cream

Locations

Country	Name	City	State
United States	Wright State Physicians	Fairborn	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microvesicle particle levels from baseline in clinically photosensitive subjects	This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.	4 Hours
Primary	Change in microvesicle particle levels from baseline post topical imipramine application	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.	4 Hours
Primary	Change in skin erythema from baseline on topical imipramine treated skin	This will be measured with a mexameter at 4 hours.	4 Hours
Primary	Change in skin erythema from baseline on topical imipramine treated skin	This will be measured with a mexameter at 24 hours.	24 Hours