The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

VA Office of Research and Development

Status and phase: Enrolling; Phase 2

Conditions: Imipramine; Photodynamic Therapy; Actinic Keratosis

Treatments: Drug: Imipramine; Other: Control Vehicle

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06778434

ONCE-001-24S

IRB-2024-674 (Other Identifier)

IRB-2024-639 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics
• Skin type must be "Fair", Fitzpatrick type I or II, due to the presence of actinic damage in this population.
• Subjects must have a VA physician's order to receive PDT treatment on their 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.
• Has stable transportation to attend study visits at DVA

Exclusion criteria

• Currently taking any tricyclic antidepressants (TCAs)
• Currently taking any selective serotonin reuptake inhibitor (SSRI)
• Has Porphyria
• Large tattoos in areas to be tested
• Pregnancy or nursing
• Taking any oral or topical medications that could interfere with the PDT
• Active rashes in the areas

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Imipramine and Control Vehicle on Forearms

Experimental group

Description:

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

Treatment:

Other: Control Vehicle

Drug: Imipramine

Imipramine and Control Vehicle on Face

Experimental group

Description:

10% imipramine and control vehicle (1.5 ml each) are applied on one side of the face for 1 hour.

Treatment:

Other: Control Vehicle

Drug: Imipramine