Testing a cream to reduce skin reactions to sunlight in sensitive individuals
Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
This study tests if a cream can help people who are sensitive to sunlight by reducing skin reactions after they are exposed to UV light.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Wright State University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Fairborn, Ohio) |
| Trial ID | NCT04520217 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of topical imipramine on individuals with photosensitivity, specifically looking at the release of microvesicle particles (MVP) following ultraviolet B (UVB) exposure. Researchers will first determine if photosensitive subjects exhibit increased MVP levels after UVB treatment. Then, they will investigate whether the application of imipramine cream can inhibit this MVP release and reduce erythema, or skin reddening, caused by UVB exposure. The study will involve adult participants aged 18 to 50 who self-identify as photosensitive.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 who self-identify as photosensitive and can provide informed consent.
Not a fit: Patients with underlying conditions affecting wound healing or those taking photosensitizing medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for managing skin reactions in photosensitive patients.
How similar studies have performed: While the specific use of imipramine for this purpose may be novel, studies on topical treatments for photosensitivity have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Fairborn, Ohio
- Wright State Physicians — Fairborn, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey B Travers, MD, PhD — Wright State University
- Study coordinator: Manager Clinical Research Operations
- Email: pturesearch@wrightstatephysicians.org
- Phone: 937-245-7500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.