Study on 5-Fluorouracil and Calcipotriene Creams for Treating Low-Risk Skin Cancer

Sponsor: Boston University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05381597

Provider View

This clinical trial is testing two different creams to treat low-risk skin cancers, specifically superficial basal cell carcinoma and squamous cell carcinoma in situ. The study aims to find out if a combination cream can clear these skin cancers with a shorter treatment period.

Patient Parameters

Program Overview

The study will compare two creams for treating low-risk skin cancers: superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). One cream, 5-Fluorouracil, is already approved for treating these cancers and is commonly used. The other is a combination cream made of 5-Fluorouracil and Calcipotriene, which has shown promise in clearing pre-cancerous skin conditions and preventing future skin cancers. The study will test if this combination cream can clear the cancers in a shorter time (7-14 days) compared to the usual 4-week treatment with 5-Fluorouracil alone. Participants will be monitored for three years with regular check-ups every six months. If the cancer is not cleared, further tests and standard treatments will be provided.

Eligibility Criteria

Inclusion Criteria

  • Speak English.
  • Have a previously untreated, biopsy-confirmed superficial basal cell carcinoma (sBCC) or squamous cell carcinoma in situ (SCCis) on the scalp, trunk, neck, or limbs (but not on hands, feet, or genital areas) that is less than 2 cm in size.
  • Have a previously untreated, biopsy-confirmed sBCC or SCCis on the face, hands, feet, or genital areas and are not suitable for surgery or choose not to have surgery.
  • Willing to follow all study requirements and attend additional study-related clinic visits.
  • Can have multiple lesions in the study as long as they are more than 2 cm apart.
  • If a woman is of childbearing age, must agree to take a pregnancy test before starting treatment and use birth control during treatment. Options include abstinence, birth control pills, IUD, implant, patch, or ring. No birth control is needed after treatment ends.

Exclusion Criteria

  • Have had treatment within 2 cm of the target skin cancer.
  • Have lesions around the eyes.
  • Have lesions that were treated before.
  • Have an allergy to any ingredients in the study medications.
  • Have had a solid organ transplant or are currently on immunosuppressive medication.
  • Have genetic disorders that increase skin cancer risk.
  • Have been exposed to arsenic.
  • Have cutaneous T-cell lymphoma.
  • Have had radiation therapy at the site of the skin cancer.
  • Are pregnant or breastfeeding.
  • Have had psoralen plus UVA treatment at the site.
  • Have a very high risk of mortality at the start of the study.
  • Have a deficiency in the DPD enzyme.
  • Have high calcium levels or vitamin D toxicity.
  • Have lesions that extend into the mouth, nose, or genital areas.

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