RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-01-19
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05688904

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ages 18 and older
  2. * Skin type must be "Fair", Fitzpatrick type I to III, due to the presence of actinic damage in this population.
  3. * Subjects need to have a physician's order to receive PDT treatment on their face, scalp or forearms.
  4. * Willing to participate and understand the informed consent document.
  5. * Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT.
  1. * Those currently taking any tricyclic antidepressants (TCAs)
  2. * Those currently taking any selective serotonin reuptake inhibitor (SSRI)
  3. * Those with porphyria
  4. * Large tattoos in the treated areas
  5. * Pregnancy or nursing
  6. * Taking any oral or topical medications that could interfere with the PDT (Appendix A)
  7. * Active rashes in the area

Contacts and Locations

Study Contact

Manager, Clinical Research Operations
CONTACT
937-245-7500
pturesearch@wrightstatephysicians.org
Regulatory Specialist
CONTACT
937-245-7500
pturesearch@wrightstatephysicians.org

Principal Investigator

Craig Rohan, MD
PRINCIPAL_INVESTIGATOR
Wright State University

Study Locations (Sites)

Wright State Physicians
Fairborn, Ohio, 45324
United States

Collaborators and Investigators

Sponsor: Wright State University

  • Craig Rohan, MD, PRINCIPAL_INVESTIGATOR, Wright State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-19
Study Completion Date2028-03

Study Record Updates

Study Start Date2023-01-19
Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

  • Imipramine
  • Photodynamic Therapy
  • Actinic Keratosis