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

Phase 1

Recruiting

• Conditions: Imipramine; Photodynamic Therapy; Actinic Keratosis
• Interventions: Other: Vehicle; Drug: Imipramine

• Registration Number: NCT05688904
• Lead Sponsor: Wright State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-18
• Study Start: 2023-01-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Male or female ages 18 and older
• Skin type must be "Fair", Fitzpatrick type I to III, due to the presence of actinic damage in this population.
• Subjects need to have a physician's order to receive PDT treatment on their face, scalp or 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.

Exclusion Criteria

• Those currently taking any tricyclic antidepressants (TCAs)
• Those currently taking any selective serotonin reuptake inhibitor (SSRI)
• Those with porphyria
• Large tattoos in the treated areas
• Pregnancy or nursing
• Taking any oral or topical medications that could interfere with the PDT (Appendix A)
• Active rashes in the area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle
Imipramine	Imipramine	Topical 4% Imipramine

Primary Outcome Measures

Name	Time	Method
Number of precancerous actinic keratosis present from baseline.	6 months post PDT treatment	Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.

Secondary Outcome Measures

Name	Time	Method
Change in itch level due to photodynamic therapy (PDT) from baseline.	6 months post PDT treatment	The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Change in pain level due to photodynamic therapy (PDT) from baseline.	6 months post PDT treatment	The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)

Trial Locations

Locations (1)

Wright State Physicians; 🇺🇸 Fairborn, Ohio, United States