The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Description

The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.

Conditions

Imipramine, Photodynamic Therapy, Actinic Keratosis

Study Overview

Study Details

Study overview

The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.

Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Condition
Imipramine
Intervention / Treatment

-

Contacts and Locations

Fairborn

Wright State Physicians, Fairborn, Ohio, United States, 45324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female ages 18 and older
  • * Skin type must be "Fair", Fitzpatrick type I to III, due to the presence of actinic damage in this population.
  • * Subjects need to have a physician's order to receive PDT treatment on their face, scalp or forearms.
  • * Willing to participate and understand the informed consent document.
  • * Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT.
  • * Those currently taking any tricyclic antidepressants (TCAs)
  • * Those currently taking any selective serotonin reuptake inhibitor (SSRI)
  • * Those with porphyria
  • * Large tattoos in the treated areas
  • * Pregnancy or nursing
  • * Taking any oral or topical medications that could interfere with the PDT (Appendix A)
  • * Active rashes in the area

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wright State University,

Craig Rohan, MD, PRINCIPAL_INVESTIGATOR, Wright State University

Study Record Dates

2028-03