Clinical trial · Interventional
The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans
Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
| Imipramine | — | UNRESOLVED | — |
| Photodynamic Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Vehicle | Other | — | UNRESOLVED |
| Imipramine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Imipramine and Control Vehicle on Forearms
- description
- 10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.
- interventionNames
- Drug: Imipramine
- Other: Control Vehicle
- type
- EXPERIMENTAL
- label
- Imipramine and Control Vehicle on Face
- description
- 10% imipramine and control vehicle (1.5 ml each) are applied on one side of the face for 1 hour.
- interventionNames
- Drug: Imipramine
- Other: Control Vehicle
Primary outcomes (3)
- measure
- (Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available