Topical Imipramine Cream for Photosensitivity

Phase 1

Recruiting

Led By Jeffrey B Travers, MD, PhD

Research Sponsored by Wright State Physicians

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female and Male adult subjects age 18 to 50

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial is testing a topical cream to see if it can prevent abnormal reactions to sunlight, and if it can block the release of microvesicle particles after ultraviolet B treatment.

Who is the study for?

This trial is for adults aged 18-50 with photosensitivity, who can provide their medical history and aren't using medications that increase sensitivity to light. Pregnant or nursing women, recent tanning bed users, those on certain antidepressants or anti-inflammatories, and individuals with abnormal scarring or diseases affecting wound healing are excluded.Check my eligibility

What is being tested?

The study tests if a cream containing 4% Imipramine can prevent skin reactions like redness and microvesicle particle release after exposure to UVB light in people sensitive to sunlight. Participants will apply the cream before UVB treatment on a small skin area.See study design

What are the potential side effects?

Potential side effects of the topical Imipramine may include local skin irritation, itching, redness at the application site, and possible allergic reactions. The base cream might also cause similar mild local discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Weight Changes

Change in microvesicle particle levels from baseline post topical imipramine application

Change in skin erythema from baseline on topical imipramine treated skin

Trial Design

1Treatment groups

Experimental Treatment

Group I: 4% Imipramine Cream on UVB-Treated AreasExperimental Treatment2 Interventions

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

0 / 1Eligibility criteria met