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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

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