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Could a cream make skin cancer treatment less painful and more effective?

NCT ID NCT05688904

Symptom relief Sponsor: Wright State University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This pilot study tests whether applying a topical imipramine cream before photodynamic therapy (PDT) can reduce pain and improve treatment of actinic keratoses, which are precancerous skin lesions. Adults with fair skin who are scheduled for PDT on their face, scalp, or forearms may participate. The study will compare the combination of imipramine plus PDT against PDT alone, measuring pain levels during treatment and the number of lesions remaining after six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Topical 4% imipramine cream applied before photodynamic therapy
What this could lead to
If it works, this could make photodynamic therapy for precancerous skin lesions less painful and more effective, improving patient comfort and outcomes.
What could go wrong
This is a small pilot study, and the combination is new. It may not reduce pain or improve effectiveness, and there could be skin irritation or other side effects from the topical imipramine.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

actinic keratosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Actinic keratosis Imipramine Photodynamic therapy

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Wright State Physicians

    RECRUITING

    Fairborn, Ohio, 45324, United States

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