Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05688904

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

Led by Wright State University · Updated on 2024-04-24

24

Participants Needed

1

Research Sites

266 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female ages 18 and older
  • Skin type must be "Fair", Fitzpatrick type I to III
  • Physician's order to receive photodynamic therapy on face, scalp, or forearms
  • Willing to participate and understand informed consent
  • Willing to avoid excess sun exposure or tanning beds on treated areas
Not Eligible

You will not qualify if you...

  • Currently taking any tricyclic antidepressants (TCAs)
  • Currently taking any selective serotonin reuptake inhibitors (SSRIs)
  • Diagnosis of porphyria
  • Large tattoos in the treated areas
  • Pregnancy or nursing
  • Taking oral or topical medications that could interfere with photodynamic therapy
  • Active rashes in the treatment area

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wright State Physicians

Fairborn, Ohio, United States, 45324

Actively Recruiting

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Research Team

M

Manager, Clinical Research Operations

CONTACT

R

Regulatory Specialist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

2

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