Using topical imipramine with photodynamic therapy for skin lesions in veterans
Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans
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 |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Dayton, Ohio) |
| Trial ID | NCT06778434 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While PDT is a well-established treatment, the combination with topical imipramine has not been previously evaluated, making this a novel approach.
Eligibility criteria
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 this trial is running
Dayton, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.