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

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.

Study Overview

• Status: Recruiting
• Conditions: Actinic Keratosis; Photodynamic Therapy; Imipramine
• Intervention / Treatment: Drug: Imipramine; Other: Vehicle

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Recruiting
      • Wright State Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Other: Vehicle; Vehicle
Active Comparator: Imipramine; Topical 4% Imipramine	Drug: Imipramine; Topical 4% Imipramine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain level due to photodynamic therapy (PDT) from baseline.	The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)	Immediately post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.	The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)	10 minutes post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.	The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)	30 minutes post PDT treatment
Change in pain level due to photodynamic therapy (PDT) from baseline.	The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)	6 months post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.	The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)	Immediately post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.	The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)	10 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.	The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)	30 minutes post PDT treatment
Change in itch level due to photodynamic therapy (PDT) from baseline.	The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)	6 months post PDT treatment

Collaborators and Investigators

• Sponsor: Wright State University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Anticipated): March 1, 2028
• Study Completion (Anticipated): March 1, 2028

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Imipramine
• Other Study ID Numbers: 07286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes