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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Imipramine Photodynamic Therapy Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Imipramine

Topical 4% Imipramine

Group Type ACTIVE_COMPARATOR

Imipramine

Intervention Type DRUG

Topical 4% Imipramine

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type OTHER

Vehicle

Interventions

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Imipramine

Topical 4% Imipramine

Intervention Type DRUG

Vehicle

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No