NCT05688904

The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Wright State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.

Conditions

• Imipramine
• Photodynamic Therapy
• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Imipramine	Topical 4% Imipramine
OTHER	Vehicle	Vehicle

Timeline

• Start date: 2023-01-19
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2023-01-18
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study