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

Primary Purpose

Imipramine, Photodynamic Therapy, Actinic Keratosis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Imipramine
Vehicle
Sponsored by
Wright State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Imipramine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wright State PhysiciansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Imipramine

Vehicle

Arm Description

Topical 4% Imipramine

Vehicle

Outcomes

Primary Outcome Measures

Number of precancerous actinic keratosis present from baseline.
Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)

Full Information

First Posted
January 9, 2023
Last Updated
April 18, 2023
Sponsor
Wright State University
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1. Study Identification

Unique Protocol Identification Number
NCT05688904
Brief Title
The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
Official Title
Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
March 2028 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wright State University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Imipramine, Photodynamic Therapy, Actinic Keratosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imipramine
Arm Type
Active Comparator
Arm Description
Topical 4% Imipramine
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
Imipramine
Intervention Description
Topical 4% Imipramine
Intervention Type
Other
Intervention Name(s)
Vehicle
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Number of precancerous actinic keratosis present from baseline.
Description
Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.
Time Frame
6 months post PDT treatment
Secondary Outcome Measure Information:
Title
Change in pain level due to photodynamic therapy (PDT) from baseline.
Description
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time Frame
Immediately post PDT treatment
Title
Change in pain level due to photodynamic therapy (PDT) from baseline.
Description
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time Frame
10 minutes post PDT treatment
Title
Change in pain level due to photodynamic therapy (PDT) from baseline.
Description
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time Frame
30 minutes post PDT treatment
Title
Change in pain level due to photodynamic therapy (PDT) from baseline.
Description
The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)
Time Frame
6 months post PDT treatment
Title
Change in itch level due to photodynamic therapy (PDT) from baseline.
Description
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Time Frame
Immediately post PDT treatment
Title
Change in itch level due to photodynamic therapy (PDT) from baseline.
Description
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Time Frame
10 minutes post PDT treatment
Title
Change in itch level due to photodynamic therapy (PDT) from baseline.
Description
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Time Frame
30 minutes post PDT treatment
Title
Change in itch level due to photodynamic therapy (PDT) from baseline.
Description
The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)
Time Frame
6 months post PDT treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manager, Clinical Research Operations
Phone
937-245-7500
Email
pturesearch@wrightstatephysicians.org
First Name & Middle Initial & Last Name or Official Title & Degree
Regulatory Specialist
Phone
937-245-7500
Email
pturesearch@wrightstatephysicians.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Rohan, MD
Organizational Affiliation
Wright State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pharmacology Translational Unit
Phone
937-245-7500

12. IPD Sharing Statement

Learn more about this trial

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

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