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 — DRUG4% Imipramine Cream
- Base Cream — DRUGBase 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
- Manager Clinical Research Operations937-245-7500
- Regulatory Specialist937-245-7500
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wright State Physicians | Fairborn | Ohio | 45324 | - |
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