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Could a cancer pill ease rare, painful skin diseases?

NCT ID NCT06545695

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This early-phase trial tests whether low doses of erlotinib, a drug originally used for cancer, can improve symptoms of rare genetic skin conditions called keratinopathies. About 44 adults with confirmed diagnoses will take increasing doses over 24 weeks. The goal is to see if it reduces skin thickening, scaling, and pain, while keeping side effects manageable.

What this could mean

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

Active substance
Erlotinib (a cancer drug used at lower doses)
What this could lead to
If it works, this could point toward a treatment for rare, painful skin conditions that currently have few options.
What could go wrong
This is a very early, small trial (44 people) testing a drug that can cause side effects like rash and stomach issues. It may not work for all types of keratinopathy.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 44 people

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

Expected to start

Jul 2027

An estimate. Start dates often move.

Expected to finish

Jun 2031

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: The participant must be at least 18 years of age. The participant must have a clinically and genetically confirmed diagnosis of a keratinopathy (Epidermolytic ichthyosis/EI: KRT 1, 2, or 10 pathogenic variant; Epidermolytic palmoplantar keratoderma/PPK: KRT 9; Pachyonychia congenita/PC form of PPK: KRT 6a, 6b, 6c, 16, 17). A blood or saliva sample will be collected for genetic confirmation if the underlying genetic change has not been confirmed by a CLIA-approved laboratory. The participant must have an investigator scored IGA at screening and baseline of at least 2 (moderate) at affected sites. The participant must abstain from use of any investigational drug or biologic within 4 weeks or 5 half-lives if longer, oral retinoid or oral steroid for at least 4 weeks, and topical medications (prescription or over-the-counter) in the week before the 8-week observation period. Otherwise stable medications (at least a month before the observation period and continued) will be allowed. The participant agrees to use standard of care with respect to bathing and exfoliation/foot care, except in the week before the visits. Moisturizers/ emollients are allowed throughout the treatment period, but use must be consistent and withheld to the designated area of sampling on the arms (EI) or plantar foot (PC/PPK) for 48 hours prior to visits when skin samples are taken. The participant is willing to have blood collected for safety and biopsies for investigation of mechanism. Participant is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of the EI or PC/PPK. Participant is able and willing to follow all study instructions Exclusion Criteria: The participant has EI or PC/PPK lesions on the assessment area that are infected or require therapy to treat the infection within 7 days of enrollment. The participant has had major surgery during the past 4 weeks. Participants have received an investigational drug or biologic within 4 weeks or 5 half-lives, whichever is longer, prior to starting treatment with and during treatment with erlotinib. Participants must be off oral retinoid or oral steroid for at least 4 weeks before drug initiation. Participants who require medications and OTC supplements that inhibit/ induce CYP3A4 activity to control concurrent medical conditions. Participants with known hypersensitivity to any of the ingredients in the study medication formulation. Participants previously treated for invasive cancer within the past 5 years unless the Investigator concludes history of cancer is not confounding to safety. Participants who are pregnant, breastfeeding or planning to become pregnant during the study or within a month after the study ends. Participants of childbearing potential who are unwilling or unable to comply with contraception measures. The participant has any condition or situation which, in the Investigator's opinion, may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study. Participants deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, adherence to the study drug administration regimen and other protocol-required activities.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Department of Dermatology, Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

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