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

Phase 1

Recruiting

• Conditions: Photosensitivity; Microvesicle Particle
• Interventions: Drug: 4% Imipramine Cream; Drug: Base Cream

• Registration Number: NCT04520217
• Lead Sponsor: Wright State University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Study Start: 2022-06-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4% Imipramine Cream on UVB-Treated Areas	Base Cream	* 2g of 4% imipramine cream will be applied to the UVB-treated areas on volar forearm and back. * 2g of base cream will be applied to the UVB-treated areas on volar forearm and back. * No cream will be applied to a UVB-treated area on the back
4% Imipramine Cream on UVB-Treated Areas	4% Imipramine Cream	* 2g of 4% imipramine cream will be applied to the UVB-treated areas on volar forearm and back. * 2g of base cream will be applied to the UVB-treated areas on volar forearm and back. * No cream will be applied to a UVB-treated area on the back

Primary Outcome Measures

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

Trial Locations

Locations (1)

Wright State Physicians; 🇺🇸 Fairborn, Ohio, United States