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

NCT ID: NCT06778434

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2029-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Actinic Keratosis Imipramine Photodynamic Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Imipramine and Control Vehicle on Forearms

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

Group Type EXPERIMENTAL

Imipramine

Intervention Type DRUG

10% imipramine

Control Vehicle

Intervention Type OTHER

polyethylene glycol: dimethyl sulfoxide Solution

Imipramine and Control Vehicle on Face

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

Group Type EXPERIMENTAL

Imipramine

Intervention Type DRUG

10% imipramine

Control Vehicle

Intervention Type OTHER

polyethylene glycol: dimethyl sulfoxide Solution

Interventions

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Imipramine

10% imipramine

Intervention Type DRUG

Control Vehicle

polyethylene glycol: dimethyl sulfoxide Solution

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Travers, MD

Role: PRINCIPAL_INVESTIGATOR

Dayton VA Medical Center, Dayton, OH

Locations

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Dayton VA Medical Center, Dayton, OH

Dayton, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Craig A Rohan, MD

Role: CONTACT

Phone: (937) 245-7500

Email: [email protected]

Jeffrey Travers, MD

Role: CONTACT

Phone: (937) 268-6511

Email: [email protected]

Facility Contacts

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Elizabeth Cates, MPA

Role: primary

Christina B Knisely, MPH

Role: backup

Other Identifiers

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IRB-2024-639

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-2024-674

Identifier Type: OTHER

Identifier Source: secondary_id

ONCE-001-24S

Identifier Type: -

Identifier Source: org_study_id