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NCT Number: NCT06778434

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

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.

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Key information

Conditions

Actinic Keratosis Imipramine Keratosis Keratosis, Actinic Neoplasms Photodynamic Therapy Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imipramine

Drug

10% imipramine

Control Vehicle

Other

polyethylene glycol: dimethyl sulfoxide Solution

Primary outcomes

  1. (Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine

    Time frame: 7, 30, 90 days post-PDT treatments

    Size of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using calipers.

  2. (Forearm Arm Only): Difference in redness of Candida antigen skin test results with PDT+ imipramine

    Time frame: 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.

  3. Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the face

    Time frame: 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 side of face/scalp.

Secondary outcomes

  1. Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the forearms

    Time frame: 6, 12 months post-PDT treatment

    Differences in baseline values of AK will be obtained following PDT + vehicle/imipramine by counting and mapping each forearm/wrist.

  2. (Forearm Arm Only): Difference in gene profile of skin following treatment with PDT + imipramine

    Time frame: 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.

  3. Differences in post-PDT redness with PDT + imipramine

    Time frame: 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 on face/forearms.

  4. Differences in post-PDT pain with PDT + imipramine

    Time frame: 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 on face/forearms.

Study contacts

Contact information is provided by the study sponsor or research team.

Craig A Rohan, MD

CONTACT

[email protected]

(937) 245-7500

Jeffrey Travers, MD

CONTACT

[email protected]

(937) 268-6511 ext. 2026

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 16, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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