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Recruiting NCT06778434

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

Phase II Interventional Actinic Keratosis Imipramine Photodynamic Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Imipramine, Control Vehicle.
Who it may be relevant to
Registry conditions: Actinic Keratosis, Imipramine, Photodynamic Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans

Overview

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.

Interventions

  • Drug Imipramine
    10% imipramine
  • Other Control Vehicle
    polyethylene glycol: dimethyl sulfoxide Solution

Primary outcome measures

  • (Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine [Time frame: 7, 30, 90 days post-PDT treatments]
  • (Forearm Arm Only): Difference in redness of Candida antigen skin test results with PDT+ imipramine [Time frame: 7, 30, 90 days post-PDT treatments]
  • Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the face [Time frame: 6, 12 months post-PDT treatment]
Secondary outcome measures (4)
  • Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the forearms [Time frame: 6, 12 months post-PDT treatment]
  • (Forearm Arm Only): Difference in gene profile of skin following treatment with PDT + imipramine [Time frame: 7 days post-PDT treatment]
  • Differences in post-PDT redness with PDT + imipramine [Time frame: 10 min, 30 min, 24 hours post-PDT treatments]
  • Differences in post-PDT pain with PDT + imipramine [Time frame: 10 min, 30 min, 24 hours post-PDT treatments]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Dayton VA Medical Center, Dayton, OH — Dayton

Identifiers

NCT: NCT06778434 · ONCE-001-24S · IRB-2024-639 · IRB-2024-674

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗