Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 4% Imipramine Cream, Base Cream.
- Who it may be relevant to
- Registry conditions: Photosensitivity, Microvesicle Particle. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
Overview
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).
Interventions
- Drug 4% Imipramine Cream
4% Imipramine Cream - Drug Base Cream
Base Cream
Primary outcome measures
- Change in microvesicle particle levels from baseline in clinically photosensitive subjects [Time frame: 4 Hours]
- Change in microvesicle particle levels from baseline post topical imipramine application [Time frame: 4 Hours]
- Change in skin erythema from baseline on topical imipramine treated skin [Time frame: 4 Hours]
- Change in skin erythema from baseline on topical imipramine treated skin [Time frame: 24 Hours]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Wright State Physicians — Fairborn
Identifiers
NCT: NCT04520217 · 06919