Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Dayton VA Medical Center, Dayton, OH
RECRUITING
Dayton
Contact Information
Primary
Craig A Rohan, MD
craig.rohan@va.gov
(937) 245-7500
Backup
Jeffrey Travers, MD
Jeffrey.Travers@va.gov
(937) 268-6511
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 24
Treatments
Experimental: Imipramine (right forearm/dorsal wrist) and Control Vehicle (left forearm/dorsal wrist)
10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.
Experimental: Imipramine (left forearm/dorsal wrist) and Control Vehicle (right forearm/dorsal wrist)
10% imipramine and control vehicle (1.5 ml each) are applied on designated separate dorsal forearm.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov