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Can a Two-Drug cream clear precancerous skin spots even when immunity is suppressed?

NCT ID NCT07794059

Disease control Sponsor: Cedars-Sinai Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests a topical cream combining 5-fluorouracil and calcipotriene as a field treatment for actinic keratoses, which are rough, precancerous skin spots caused by sun damage. Researchers will compare how well the cream clears these spots in 32 people with normal immune function and 64 solid organ transplant recipients who take immunosuppressive drugs. The main goal is to measure the change in the number of actinic keratoses after nine weeks of treatment, along with how complete the clearance is and what skin reactions occur.

What this could mean

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

Active substance
A topical combination of 5-fluorouracil and calcipotriene (5FU/C)
What this could lead to
If it works, this could confirm a short topical cream course as an effective field treatment for actinic keratoses, including in people with suppressed immune systems.
What could go wrong
The trial is small and early, and results may differ between immunocompetent and immunosuppressed participants. Skin reactions from the cream can be uncomfortable, and clearance may not be complete or lasting.

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.

Participants

About 96 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

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.

Who is studied

Inclusion Criteria: * Individuals 18 years old or older are included * Presence of 4 to 15 clinically visible and discrete actinic keratoses in a 100-cm2 contiguous area on the face, non-hair bearing scalp, or the upper extremities (including the hand). * Solid organ transplantation (kidney, lung, heart, liver, and/or pancreas) on immunosuppressive medications for at least one year prior to the start of the study Exclusion Criteria: * Active skin cancer * Recent use of field cancerization within the preceding 12 months in the field of treatment * Use of nicotinamide or vitamin A derivatives (which are systemic agents intended for NMSC prevention). * Any records flagged "break the glass" or "research opt out." * Allergy or hypersensitivity to 5-Fluorouracil or Calcipotriene or inactive components of compounded product * Pregnant and breastfeeding patients * Allergy to peanut as some formulation of 5FU may contain peanut oil. * Allergy or hypersensitivity to Trolamine-NF, PenDe

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: * Individuals 18 years old or older are included * Presence of 4 to 15 clinically visible and discrete actinic keratoses in a 100-cm2 contiguous area on the face, non-hair bearing scalp, or the upper extremities (including the hand). * Solid organ transplantation (kidney, lung, heart, liver, and/or pancreas) on immunosuppressive medications for at least one year prior to the start of the study Exclusion Criteria: * Active skin cancer * Recent use of field cancerization within the preceding 12 months in the field of treatment * Use of nicotinamide or vitamin A derivatives (which are systemic agents intended for NMSC prevention). * Any records flagged "break the glass" or "research opt out." * Allergy or hypersensitivity to 5-Fluorouracil or Calcipotriene or inactive components of compounded product * Pregnant and breastfeeding patients * Allergy to peanut as some formulation of 5FU may contain peanut oil. * Allergy or hypersensitivity to Trolamine-NF, PenDerm Cream Base, and Propylene Glycol

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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 keratoses

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90211, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

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