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Imipramine + Photodynamic Therapy for Actinic Keratosis

Phase 1
Recruiting
Led By Craig Rohan, MD
Research Sponsored by Wright State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects need to have a physician's order to receive PDT treatment on their face, scalp or forearms
Skin type must be "Fair", Fitzpatrick type I to III, due to the presence of actinic damage in this population
Must not have
Those with porphyria
Those currently taking any tricyclic antidepressants (TCAs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post pdt treatment

Summary

This trial tests combining two FDA-approved treatments (Imipramine & PDT) to reduce pain & improve effectiveness in treating pre-cancerous skin lesions.

Who is the study for?
This trial is for adults over 18 with fair skin (Fitzpatrick type I to III) who have many pre-cancerous lesions called actinic keratosis and are prescribed photodynamic therapy (PDT) for their face, scalp, or forearms. Participants must avoid excess sun exposure and tanning beds. Excluded are those with porphyria, on certain antidepressants or SSRIs, pregnant or nursing women, people with active rashes or large tattoos in the area, and anyone taking medications that interfere with PDT.
What is being tested?
The study tests topical Imipramine applied before PDT to see if it reduces pain from the treatment and improves its effectiveness against actinic keratosis. Both treatments are FDA-approved separately; this trial examines their combined use which hasn't been studied before.
What are the potential side effects?
While specific side effects of combining Imipramine with PDT aren't listed here, common ones from each may include skin irritation from Imipramine and redness, swelling or a burning sensation from PDT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a doctor's order for PDT treatment on my face, scalp, or forearms.
Select...
I have fair skin, prone to sunburns, Fitzpatrick type I to III.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have porphyria.
Select...
I am currently taking tricyclic antidepressants.
Select...
I am currently taking an SSRI medication.
Select...
I currently have active rashes.
Select...
I have large tattoos in the areas that will be treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post pdt treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post pdt treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of precancerous actinic keratosis present from baseline.
Secondary study objectives
Change in itch level due to photodynamic therapy (PDT) from baseline.
Change in pain level due to photodynamic therapy (PDT) from baseline.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ImipramineActive Control1 Intervention
Topical 4% Imipramine
Group II: VehiclePlacebo Group1 Intervention
Vehicle

Find a Location

Who is running the clinical trial?

Wright State UniversityLead Sponsor
46 Previous Clinical Trials
55,284 Total Patients Enrolled
Craig Rohan, MDPrincipal InvestigatorWright State University
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Imipramine Clinical Trial Eligibility Overview. Trial Name: NCT05688904 — Phase 1
Imipramine Research Study Groups: Vehicle, Imipramine
Imipramine Clinical Trial 2023: Imipramine Highlights & Side Effects. Trial Name: NCT05688904 — Phase 1
Imipramine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05688904 — Phase 1
~15 spots leftby Mar 2028
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