Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2022
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedStudy Start
First participant enrolled
June 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 27, 2025
January 1, 2025
4.5 years
August 17, 2020
January 24, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
Change in skin erythema from baseline on topical imipramine treated skin
This will be measured with a mexameter at 4 hours.
4 Hours
Change in skin erythema from baseline on topical imipramine treated skin
This will be measured with a mexameter at 24 hours.
24 Hours
Study Arms (1)
4% Imipramine Cream on UVB-Treated Areas
EXPERIMENTAL* 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wright State Physicians
Fairborn, Ohio, 45324, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey B Travers, MD, PhD
Wright State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2020
First Posted
August 20, 2020
Study Start
June 6, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 27, 2025
Record last verified: 2025-01