Using topical imipramine with photodynamic therapy for skin lesions in veterans
Official title: Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans
Run by VA Office of Research and Development · NCT06778434 · Data updated 2026-11-12
This study is testing if using a skin cream called imipramine along with light therapy can help veterans with precancerous skin lesions get better results from their treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Dayton, Ohio) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | March 30, 2029 |
| Study ends | March 30, 2029 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT06778434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult males and females aged 18 and older with fair skin types who have been prescribed PDT for actinic keratosis.
✕Probably not a fit
Patients currently taking tricyclic antidepressants or selective serotonin reuptake inhibitors, or those with certain skin conditions or active rashes, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of topical imipramine when used alongside photodynamic therapy (PDT) to treat actinic keratosis in veterans. PDT is a standard treatment for precancerous skin lesions, and this research aims to determine if imipramine can mitigate the immunosuppressive effects of PDT, potentially enhancing its efficacy. Participants will be recruited from the Dayton VA Medical Center, where they will receive both treatments under careful monitoring. The study focuses on adult patients with fair skin types who have been prescribed PDT for their skin conditions.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for veterans with actinic keratosis by enhancing the effectiveness of photodynamic therapy.
How similar studies have gone: While PDT is a well-established treatment, the combination with topical imipramine has not been previously evaluated, making this a novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, United States Recruiting
Study contacts
- Principal investigator: Jeffrey Travers, MD — Dayton VA Medical Center, Dayton, OH
- Study coordinator: Craig A Rohan, MD
- Email: craig.rohan@va.gov
- Phone: (937) 245-7500
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using Imipramine to Reduce Pain from Photodynamic Therapy for Skin Lesions
This study is testing if using Imipramine with photodynamic therapy can help reduce pain for people getting treatment for actinic keratosis.
-
Reformulated Levulan Kerastick plus blue‑light PDT for actinic keratoses on the upper arm
This trial will test whether applying a reformulated Levulan Kerastick (aminolevulinic acid 20%) followed by blue‑light photodynamic therapy can clear 4–8 mild-to-moderate actinic keratoses on one upper arm in adults.
-
Reformulated Levulan Kerastick with blue light for actinic keratosis on the face or bald scalp
This Phase 3 trial will test whether reformulated Levulan Kerastick (aminolevulinic acid 20%) followed by blue light photodynamic therapy clears 4–8 mild-to-moderate actinic keratosis lesions in adults.
-
Comparing two treatments for persistent low-grade cervical lesions caused by high-risk HPV
This study is testing whether a new light therapy or a laser treatment is better at helping women with long-lasting low-grade cervical lesions caused by high-risk HPV.
-
Multimodal Laser Treatment for Photodamaged Facial Skin
A randomized split-face study tests a combination of three lasers and light therapy to improve sun-damaged facial skin and potentially help prevent skin cancer in adults with actinic keratosis.
-
Pharmacokinetic test of reformulated Levulan Kerastick for actinic keratosis on forearms or face
This study tests how the reformulated Levulan Kerastick behaves in the body when used on actinic keratosis lesions on the arms or face, followed by blue-light treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.