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

Part of paid clinical trials in Fairborn, Ohio.

Sponsor
Wright State University
Study ID
NCT05688904
Phase
PHASE1
Status
Recruiting
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Conditions

  • Actinic Keratosis
  • Imipramine
  • Photodynamic Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Imipramine — DRUG
    Topical 4% Imipramine
  • Vehicle — OTHER
    Vehicle

Study Details

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.

Key Dates

Start date
Jan 19, 2023
Status verified
Apr 2024
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Active Comparator: Imipramine
    Topical 4% Imipramine
  • Placebo Comparator: Vehicle
    Vehicle

Primary Outcome Measure

Number of precancerous actinic keratosis present from baseline. [ Time Frame: 6 months post PDT treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wright State PhysiciansFairbornOhio45324
Pharmacology Translational Unit
937-245-7500

Find similar trials in Fairborn, OH

By research site
Wright State Physicians· Fairborn, OH

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