Fairborn, Ohio 45324

  • Microvesicle Particle

Purpose:

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).


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)


Study is Available At:


Original ID:

06919


NCT ID:

NCT04520217


Secondary ID:


Study Acronym:


Brief Title:

Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects


Official Title:

Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wright State University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jeffrey B Travers, MD, PhD
Principal Investigator
Wright State University
Primary Contact:Manager Clinical Research Operations
937-245-7500
pturesearch@wrightstatephysicians.org
Backup Contact:Regulatory Specialist
937-245-7500
pturesearch@wrightstatephysicians.org

Study Dates

Start Date:June 6, 2022
Completion Date:December 2022
Completion Type:Anticipated
Primary Completion Date:December 2022
Primary Completion Type:Anticipated
Verification Date:July 2022
Last Changed Date:July 13, 2022
First Received Date:August 17, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in microvesicle particle levels from baseline in clinically photosensitive subjects
Time Frame:4 Hours
Safety Issues:False
Description:This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.
Outcome Type:Primary Outcome
Measure:Change in microvesicle particle levels from baseline post topical imipramine application
Time Frame:4 Hours
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in skin erythema from baseline on topical imipramine treated skin
Time Frame:4 Hours
Safety Issues:False
Description:This will be measured with a mexameter at 4 hours.
Outcome Type:Primary Outcome
Measure:Change in skin erythema from baseline on topical imipramine treated skin
Time Frame:24 Hours
Safety Issues:False
Description:This will be measured with a mexameter at 24 hours.

Study Interventions

Intervention Type:Drug
Name:4% Imipramine Cream
Description:4% Imipramine Cream
Arm Name:4% Imipramine Cream on UVB-Treated Areas
Intervention Type:Drug
Name:Base Cream
Description:Base Cream
Arm Name:4% Imipramine Cream on UVB-Treated Areas

Study Arms

Study Arm Type:Experimental
Arm Name:4% Imipramine Cream on UVB-Treated Areas
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wright State University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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