Recruiting
Phase 2

Topical Imipramine

Sponsor:

VA Office of Research and Development

Code:

NCT06778434

Conditions

Actinic Keratosis

Imipramine

Photodynamic Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Imipramine

Control Vehicle

Study Details

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 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.

Conditions

Actinic Keratosis

Imipramine

Photodynamic Therapy

Study ID

NCT06778434

Start date

Apr 1, 2025

Status verified date

Dec, 2025

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Mar 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Imipramine

10% imipramine

Control Vehicle

polyethylene glycol: dimethyl sulfoxide Solution

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 ]
  • (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 ]

Central Contacts and Locations

Central contacts

Craig A Rohan, MD

(937) 245-7500craig.rohan@va.gov

Jeffrey Travers, MD

(937) 268-6511Jeffrey.Travers@va.gov

Locations

Dayton VA Medical Center, Dayton, OH

Recruiting

Dayton, Ohio, United States, 45428

Contacts

Elizabeth Cates, MPA

(937) 245-7500elizabeth.cates@wrightstatephysicians.org

Christina B Knisely, MPH

(937) 724-7500Christina.knisely@wright.edu

Principal Investigator:

Jeffrey Travers, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-12-22.