Recruiting
Phase 1

Topical Imipramine

Sponsor:

Wright State University

Code:

NCT04520217

Conditions

Photosensitivity

Microvesicle Particle

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

4% Imipramine Cream

Base Cream

Study Details

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).

Conditions

Photosensitivity

Microvesicle Particle

Study ID

NCT04520217

Start date

Jun 6, 2022

Status verified date

Jan, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 4% Imipramine Cream on UVB-Treated Areas

  • 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

4% Imipramine Cream

4% Imipramine Cream

Base Cream

Base Cream

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Manager Clinical Research Operations

937-245-7500pturesearch@wrightstatephysicians.org

Regulatory Specialist

937-245-7500pturesearch@wrightstatephysicians.org

Locations

Wright State Physicians

Recruiting

Fairborn, Ohio, United States, 45324

More Information

Sponsor

Wright State University

Last update posted

Jan 27, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wright State University on 2025-01-27.