5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Combination cream of 5-fluorouracil and calcipotriene
DrugApply 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
DrugApply 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Combination cream of 5-fluorouracil and calcipotrieneExperimental treatment 1 intervention
Group B: 5-fluorouracil creamActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
3 months2
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.
Time frame
3 yearsSecondary outcomes
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.
Time frame
3 months2
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.
Time frame
3 months3
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.
Time frame
3 months4
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.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov