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

Phase 2

Recruiting

• Conditions: Actinic Keratosis; Imipramine; Photodynamic Therapy
• Interventions: Drug: Imipramine; Other: Control Vehicle

• Registration Number: NCT06778434
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-16
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-28
• Primary Completion: 2029-03-30
• Study Completion: 2029-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imipramine (right forearm/dorsal wrist) and Control Vehicle (left forearm/dorsal wrist)	Imipramine	10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.
Imipramine (right forearm/dorsal wrist) and Control Vehicle (left forearm/dorsal wrist)	Control Vehicle	10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.
Imipramine (left forearm/dorsal wrist) and Control Vehicle (right forearm/dorsal wrist)	Imipramine	10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.
Imipramine (left forearm/dorsal wrist) and Control Vehicle (right forearm/dorsal wrist)	Control Vehicle	10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.

Primary Outcome Measures

Name	Time	Method
Difference in areas of Candida antigen skin test results with PDT+ imipramine	7, 30, 90 days post-PDT treatments	Size of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using calipers
Difference in redness of Candida antigen skin test results with PDT+ imipramine	7, 30, 90 days post-PDT treatments	Redness of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using mexameter device and thermal imaging

Secondary Outcome Measures

Name	Time	Method
Difference in numbers of precancerous AK skin lesions with PDT + imipramine	6, 12 months post-PDT treatment	Differences in baseline values of AK will be obtained following PDT + vehicle/imipramine by counting and mapping on each forearm/wrist
Difference in gene profile of skin following treatment with PDT + imipramine	7 days post-PDT treatment	Differences in transcriptome RNA values from baseline will be obtained following PDT + vehicle/impramine by use of tissue RNA-seq with a commercial dermal transcriptomal patch.
Differences in post-PDT redness with PDT + imipramine	10 min, 30 min, 24 hours post-PDT treatments	Differences in redness following PDT + imipramine vs PDT + vehicle from baseline values will be obtained using a mexameter device and thermal imaging.
Differences in post-PDT pain with PDT + imipramine	10 min, 30 min, 24 hours post-PDT treatments	Differences in pain following PDT + imipramine vs PDT + vehicle from baseline values will be obtained using a visual analog scale

Trial Locations

Locations (1)

Dayton VA Medical Center, Dayton, OH; 🇺🇸 Dayton, Ohio, United States