Actively Recruiting
Combination of 5-Fluorouracil and Calcipotriene for Treating Superficial Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ
Led by Boston University ยท Updated on 2025-11-28
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two creams to treat low-risk skin cancers, specifically superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). The study evaluates whether a combination cream of 5-fluorouracil and calcipotriene applied for a shorter duration can clear these cancers effectively compared to the standard 5-fluorouracil cream used for 4 weeks. This pilot randomized single-blinded trial is sponsored by Boston University and includes follow-up for up to three years to monitor cancer clearance and recurrence. Participants will be randomly assigned to receive either the combination cream applied twice daily for 7 days, which may be extended to 14 days based on evaluation, or the standard 5-fluorouracil cream applied twice daily for 28 days. The creams are applied to the lesion and a surrounding 0.5 cm area of skin. The study treatments are compared by assessing the clearance of cancer lesions clinically. During the study, participants will have their lesions examined at 3 months and followed for up to 3 years with visits at 6 months and yearly intervals. If lesions are not clearly cleared, biopsies will be performed and standard care will be provided. Researchers will track clearance rates, recurrence, and side effects such as pain, redness, scaling, itching, and burning during treatment. Participant adherence and satisfaction with treatment will also be assessed over the study period.
CONDITIONS
Brief Title
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English-speaking
- Biopsy-proven superficial basal cell carcinoma or squamous cell carcinoma in situ less than 2 cm on scalp, trunk, neck, or extremities (excluding hands, feet, genitalia)
- Biopsy-proven superficial basal cell carcinoma or squamous cell carcinoma in situ on face, hands, feet, or genitalia if surgery is declined or not an option
- Willing to follow all study procedures and attend follow-up visits
- Multiple lesions allowed if they are more than 2 cm apart
- Women of childbearing potential must agree to pregnancy testing before treatment and use birth control during treatment
You will not qualify if you...
- Current or prior field treatment within 2 cm of the target lesion
- Lesions near the eyes (periorbital lesions)
- Previously treated lesions
- Allergy to any ingredients in study medications
- History of solid organ transplant or current immunosuppression
- Genetic disorders with high skin cancer risk
- Arsenic exposure
- Cutaneous T-cell lymphoma
- Prior or current radiation therapy at the lesion site
- Pregnant or breastfeeding women
- Prior psoralen plus ultraviolet light treatment at lesion site
- Very high mortality risk at study start
- Dihydropyrimidine dehydrogenase enzyme deficiency
- Hypercalcemia or vitamin D toxicity
- Lesions extending into oral, nasal, or genital mucosa
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 to 14 days or 28 days depending on treatment group
Participants apply the assigned cream to the lesion and surrounding skin twice daily. Depending on the group, treatment lasts 7 to 14 days or 28 days.
1 to 2 visits including evaluation at 7 days for possible treatment extension
Duration - Up to 3 years
Participants are monitored for clearance and recurrence of cancer lesions, as well as side effects and treatment satisfaction.
Visits at 3 months, 1 year, and 3 years
Trial Site Locations
Total: 1 location
1
Boston Medical Center Dermatology Clinic
Boston, Massachusetts, United States, 02118
Actively Recruiting
Research Team
F
Frederick Gibson, MD
A
Alexandria Riopelle, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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