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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified October 2025 by Boston University
Sponsor
Boston University
Information Provided by (Responsible Party)
Boston University
Clinicaltrials.gov Identifier
NCT05381597
Other Study ID Numbers:
H-42421
First Submitted
May 14, 2022
First Posted
May 18, 2022
Last Update Posted
November 27, 2025
Last Verified
October 2025

ClinicalTrials.gov processed this data on November 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Superficial Basal Cell CarcinomaSquamous Cell Carcinoma in Situ
Drug: Combination cream of 5-fluorouracil and calcipotrieneDrug: 5-fluorouracil cream

Study Design

Study TypeInterventional
Actual Enrollment200 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleCombination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ
Study Start DateOctober 14, 2022
Actual Primary Completion Date1yr 1w from now
Actual Study Completion Date1yr 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Combination cream of 5-fluorouracil and calcipotriene
Participants randomized to this group will receive treatment with the combination cream consisting of 5-fluorouracil and calcipotriene twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.
Drug: Combination cream of 5-fluorouracil and calcipotriene
Apply the cream to the size of the lesion extending to the 0.5 cm area of skin surrounding the lesion.twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.
5-fluorouracil cream
Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days.
Drug: 5-fluorouracil cream
Apply the cream to the size of their lesion extending to the 0.5 cm area of skin surrounding the lesion twice daily for 28 days.

Outcome Measures

Primary Outcome Measures
  1. Clearance rate of cancer lesions at 3 months
    Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
  2. Clearance rate of cancer lesions at 3 years
    Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
Secondary Outcome Measures
  1. Percent of participants that experience pain during treatment
    Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). The number of participants with scores of 2 or higher will be divided by all participants.
  2. Severity of pain during treatment
    Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). Mean pain ratings will be calculated with higher mean scores suggesting more severe pain.
  3. Percent of participants that experience redness during treatment
    Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. The number of participants with scores of 2 or higher will be divided by all participants.
  4. Severity of redness during treatment
    Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. Mean redness ratings will be calculated with higher mean scores suggesting more severe redness.
  5. Day of worst redness
    For participants who experienced any redness, the mean day after treatment when the redness was worst will be calculated.
  6. Percent of participants who experienced scaling/flaking
    Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any scaling/flaking. The number of participants who responded 'yes' will be divided by all participants.
  7. Percent of participants who experienced skin itching
    Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin itching. The number of participants who responded 'yes' will be divided by all participants.
  8. Percent of participants who experienced skin burning
    Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin burning. The number of participants who responded 'yes' will be divided by all participants.
  9. Participant compliance with treatment
    Compliance with treatment will be assessed by weighing the medicine tubes after treatment completion and comparing the weight, estimated in grams from fingertip units (FTU), with the expected weight based on the how much medicine should have been used given the treatment regimen. The closer this difference is to zero, the greater the compliance.
  10. Participant satisfaction with treatment
    Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their satisfaction with the treatment from 1 to 5 where 1=very dissatisfied, 2= dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied. Mean satisfaction ratings will be calculated with higher mean scores suggesting more treatment satisfaction.
  11. Recurrence rate of cancer lesions at 1 year
    The recurrence rate is the percentage of cancer lesions that recur which is the number that recur out of the number cleared.
  12. Recurrence rate of cancer lesions at 3 years
    The recurrence rate is the percentage of cancer lesions that recur which is the number that recur out of the number cleared.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsBoston University
Locations
Boston Medical Center Dermatology Clinic | Boston Massachusetts, United States, 02118
Investigators
Principal Investigator: Bilal Fawaz, MD, Dermatology, Boston University School of Medicine