Topical Imipramine for Actinic Keratosis

Recruiting in Palo Alto (17 mi)

Overseen byJeffrey Travers, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "AK") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.

Eligibility Criteria

This trial is for US veterans with many pre-cancers on their skin, known as actinic keratosis. Participants must be candidates for photodynamic therapy (PDT) as decided by their provider. The study excludes those who cannot consent to PDT or have conditions that might interfere with the treatment.

Inclusion Criteria

I will avoid too much sun or using tanning beds on the area treated.

Has stable transportation to attend study visits at DVA

Willing to participate and understand the informed consent document

+3 more

Exclusion Criteria

I am currently taking tricyclic antidepressants.

I am currently taking an SSRI medication.

Large tattoos in areas to be tested

+4 more

Participant Groups

The study tests topical imipramine combined with PDT against a control vehicle (placebo) with PDT to see if it reduces immunosuppression and enhances treatment effectiveness. Only the combination use of imipramine is experimental; PDT alone is standard care.

2Treatment groups

Experimental Treatment

Group I: Imipramine (right forearm/dorsal wrist) and Control Vehicle (left forearm/dorsal wrist)Experimental Treatment2 Interventions

10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.

Group II: Imipramine (left forearm/dorsal wrist) and Control Vehicle (right forearm/dorsal wrist)Experimental Treatment2 Interventions

10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.