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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04520217

Enrollment

Registered

2020-08-20

Start date

2022-06-06

Completion date

2026-12-01

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microvesicle Particle, Photosensitivity

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).

Interventions

DRUG4% Imipramine Cream

4% Imipramine Cream

DRUGBase Cream

Base Cream

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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 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.
Change in skin erythema from baseline on topical imipramine treated skin	4 Hours	This will be measured with a mexameter at 4 hours.

Countries

United States

Contacts

Primary ContactManager Clinical Research Operations

pturesearch@wrightstatephysicians.org937-245-7500

Backup ContactRegulatory Specialist