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

Part of paid clinical trials in Fairborn, Ohio.

Sponsor
Wright State University
Study ID
NCT04520217
Phase
PHASE1
Status
Recruiting

Conditions

  • Microvesicle Particle
  • Photosensitivity

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • 4% Imipramine Cream — DRUG
    4% Imipramine Cream
  • Base Cream — DRUG
    Base Cream

Study Details

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).

Key Dates

Start date
Jun 6, 2022
Status verified
Jan 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 4% Imipramine Cream on UVB-Treated Areas
    * 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 Measure

Change in microvesicle particle levels from baseline in clinically photosensitive subjects [ Time Frame: 4 Hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wright State PhysiciansFairbornOhio45324-

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