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

NCT06778434 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: ONCE-001-24SIRB-2024-639IRB-2024-674
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

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

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

  7, 30, 90 days post-PDT treatments

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

  Redness of skin reactions from baseline values will be obtained following PDT + vehicle/imipramine using mexameter device and thermal imaging.

  7, 30, 90 days post-PDT treatments

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

  Differences in baseline values of AK will be obtained following PDT + vehicle/imipramine by counting and mapping on each side of face/scalp.

  6, 12 months post-PDT treatment

Secondary Outcomes (4)

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

  6, 12 months post-PDT treatment

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

  7 days post-PDT treatment

• Differences in post-PDT redness with PDT + imipramine

  10 min, 30 min, 24 hours post-PDT treatments

• Differences in post-PDT pain with PDT + imipramine

  10 min, 30 min, 24 hours post-PDT treatments

Study Arms (2)

Imipramine and Control Vehicle on Forearms

EXPERIMENTAL

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

Drug: Imipramine; Other: Control Vehicle

Imipramine and Control Vehicle on Face

EXPERIMENTAL

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

Drug: Imipramine; Other: Control Vehicle

Interventions

Imipramine DRUG

10% imipramine

Imipramine and Control Vehicle on Face; Imipramine and Control Vehicle on Forearms

Control Vehicle OTHER

polyethylene glycol: dimethyl sulfoxide Solution

Imipramine and Control Vehicle on Face; Imipramine and Control Vehicle on Forearms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Dayton VA Medical Center, Dayton, OH

Dayton, Ohio, 45428, United States

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imipramine

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey Travers, MD

  Dayton VA Medical Center, Dayton, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig A Rohan, MD

CONTACT

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

Jeffrey Travers, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)