NCT04520217 Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
| NCT ID | NCT04520217 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Wright State University |
| Condition | Photosensitivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-06-06 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2022-06-06 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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)
Contact & Investigator
Jeffrey B Travers, MD, PhD
PRINCIPAL INVESTIGATOR
Wright State University
Frequently Asked Questions
Who can join the NCT04520217 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Photosensitivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04520217 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04520217 currently recruiting?
Yes, NCT04520217 is actively recruiting participants. Contact the research team at pturesearch@wrightstatephysicians.org for enrollment information.
Where is the NCT04520217 trial being conducted?
This trial is being conducted at Fairborn, United States.
Who is sponsoring the NCT04520217 clinical trial?
NCT04520217 is sponsored by Wright State University. The principal investigator is Jeffrey B Travers, MD, PhD at Wright State University. The trial plans to enroll 40 participants.