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5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv9
  2. Notable Primary and study completion dates: Jun 2025 to Jun 2027v8
  3. Minor Site contact updatedv7
  4. Minor 2 versions Re-verified since Nov 9, 2022, no change to tracked fieldsv5-v6
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 1
    • Start date changed from estimate of Oct 2022 to Oct 15, 2022
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Start date: Sep 2022 to Oct 2022v3
  2. Notable Start date: Jul 2022 to Sep 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers. The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place.
Trial Details
NCT Number NCT05381597
Lead Sponsor Boston University
Conditions
(from sponsor)
Superficial Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ
Related terms Squamous Intraepithelial Lesions
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov