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

Part of paid clinical trials in Dayton, Ohio.

Sponsor
VA Office of Research and Development
Study ID
NCT06778434
Phase
PHASE2
Status
Recruiting
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Conditions

  • Actinic Keratosis
  • Imipramine
  • Photodynamic Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Imipramine — DRUG
    10% imipramine
  • Control Vehicle — OTHER
    polyethylene glycol: dimethyl sulfoxide Solution

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Dec 2025
Primary completion
Mar 30, 2029
Completion
Mar 30, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Imipramine and Control Vehicle on Forearms
    10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.
  • Experimental: 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.

Primary Outcome Measure

(Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine [ Time Frame: 7, 30, 90 days post-PDT treatments ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dayton VA Medical Center, Dayton, OHDaytonOhio45428
Elizabeth Cates, MPA
[email protected]
(937) 245-7500
Christina B Knisely, MPH
[email protected]
(937) 724-7500
Jeffrey Travers, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dayton VA Medical Center, Dayton, OH· Dayton, OH

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