Using Imipramine to Reduce Pain from Photodynamic Therapy for Skin Lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests the combination of topical Imipramine and photodynamic therapy (PDT) to assess its effect on pain management for patients with actinic keratosis. PDT is a standard dermatological treatment for precancerous skin lesions, and while both treatments are FDA-approved, their combined use has not been previously evaluated. The study aims to determine if Imipramine can enhance the effectiveness of PDT and reduce associated pain. Participants will be individuals who have been recommended PDT by their dermatologist due to multiple actinic keratosis lesions.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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

Where it's running

• Wright State Physicians
  Fairborn, Ohio, United States Recruiting

Study contacts

• Principal investigator: Craig Rohan, MD — Wright State University
• Study coordinator: Manager, Clinical Research Operations
• Email: pturesearch@wrightstatephysicians.org
• Phone: 937-245-7500

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• Pharmacokinetic test of reformulated Levulan Kerastick for actinic keratosis on forearms or face

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.