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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post pdt treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post pdt treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of precancerous actinic keratosis present from baseline.

Secondary outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wright State UniversityLead Sponsor

41 Previous Clinical Trials

54,858 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Imipramine been granted regulatory clearance?

"Imipramine's safety is assessed to be a 1 due to its Phase 1 status, implying that there are only minimal data points confirming efficacy and security."

Answered by AI

Are volunteers currently being sought for this experiment?

"According to clinicaltrials.gov, the recruitment period of this trial concluded on September 1st 2023; therefore it is not actively seeking out participants at present. However, 28 other medical studies are currently recruiting individuals for their trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05688904.

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