NCT04520217 · Wright State University
Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
What this study is about
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.
View original scientific description
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
This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.
Change in microvesicle particle levels from baseline post topical imipramine application
Time frame: 4 Hours
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.
Change in skin erythema from baseline on topical imipramine treated skin
Time frame: 4 Hours
This will be measured with a mexameter at 4 hours.
Change in skin erythema from baseline on topical imipramine treated skin
Time frame: 24 Hours
This will be measured with a mexameter at 24 hours.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Fairborn, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2025 · Source of record for eligibility and locations