Health TrialsbyHealthPanel

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

ConditionsPhotosensitivityMicrovesicle Particle
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorWright State University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 4% Imipramine Cream

    Drug

    4% Imipramine Cream

  • Base Cream

    Drug

    Base Cream

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: 4% Imipramine Cream on UVB-Treated AreasExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
4 Hours
2

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.

Time frame
4 Hours
3

Change in skin erythema from baseline on topical imipramine treated skin

This will be measured with a mexameter at 4 hours.

Time frame
4 Hours
4

Change in skin erythema from baseline on topical imipramine treated skin

This will be measured with a mexameter at 24 hours.

Time frame
24 Hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wright State University

Lead sponsor

Source ClinicalTrials.gov
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