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Trial Title:
The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
NCT ID:
NCT05688904
Condition:
Imipramine
Photodynamic Therapy
Actinic Keratosis
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Imipramine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Imipramine
Description:
Topical 4% Imipramine
Arm group label:
Imipramine
Intervention type:
Other
Intervention name:
Vehicle
Description:
Vehicle
Arm group label:
Vehicle
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wright State Physicians
Address:
City:
Fairborn
Zip:
45324
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pharmacology Translational Unit
Phone:
937-245-7500
Start date:
January 19, 2023
Completion date:
March 2028
Lead sponsor:
Agency:
Wright State University
Agency class:
Other
Source:
Wright State University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05688904