Could a 7-Day cream replace 4 weeks of treatment for skin cancer?
NCT ID NCT05381597
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a combination cream (5-fluorouracil plus calcipotriene) applied for just 7 to 14 days can clear two types of low-risk skin cancer: superficial basal cell carcinoma and squamous cell carcinoma in situ. About 200 adults will receive either the combination cream or the standard 4-week 5-fluorouracil cream. Researchers will check if the cancer is gone at 3 months and again at 3 years, and also track any pain during treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- combination cream of 5-fluorouracil and calcipotriene
- What this could lead to
- If it works, this could offer a shorter, more convenient cream treatment for certain skin cancers, reducing treatment time from 4 weeks to 1-2 weeks.
- What could go wrong
- This is a mid-stage trial with only 200 participants. The combination cream is not yet approved for these cancers, and results may not apply to all skin cancer types or locations.
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * English-speaking * Having a previously untreated, biopsy-proven Superficial Basal Cell Carcinoma (sBCC) or Squamous Cell Carcinoma in Situ (SCCis) of the skin \<2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia * Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates * Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits * Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other * If a woman is of childbearing potential, the participant must be willing to take a pregnancy test before starting treatment and be on some form of birth control while receiving treatment. Birth control can include abstinence, oral contraceptive pill, intrauterine device, implanted birth control device, birth control patch, or the vaginal ring. The patient does not need to be on any form of birth control after they end therapy. Exclusion Criteria: * Current or prior field treatment within 2 cm of the target BCC or SCCis * Periorbital lesions * Lesions that have been previously treated * Known allergy to any of the study medication ingredients * History of solid organ transplant or current immunosuppression * Genetic disorders associated with high skin cancer risk * Arsenic exposure * Cutaneous T-cell lymphoma * Current or prior radiation therapy at the site of the sBCC or SCCis * Women who are pregnant or currently breastfeeding * Prior psoralen plus Ultraviolet light (UVA) treatment at the site * Very high mortality risk at the start of the study * Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency * Demonstrated hypercalcemia or evidence of vitamin D toxicity * Lesions that extend into the oral, nasal or genital mucosa
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Boston Medical Center Dermatology Clinic
RECRUITINGBoston, Massachusetts, 02118, United States
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