Photosensitivity Clinical Trial
Official title:
Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
NCT number | NCT04520217 |
Other study ID # | 06919 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | June 6, 2022 |
Est. completion date | December 2026 |
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).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Wright State Physicians | Fairborn | Ohio |
Lead Sponsor | Collaborator |
---|---|
Wright State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in microvesicle particle levels from baseline in clinically photosensitive subjects | This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2. | 4 Hours | |
Primary | Change in microvesicle particle levels from baseline post topical imipramine application | This will be measured in skin biopsies with topical imipramine applied. Biopsies are obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2. | 4 Hours | |
Primary | Change in skin erythema from baseline on topical imipramine treated skin | This will be measured with a mexameter at 4 hours. | 4 Hours | |
Primary | Change in skin erythema from baseline on topical imipramine treated skin | This will be measured with a mexameter at 24 hours. | 24 Hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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