Phase
Condition
Squamous Cell Carcinoma
Carcinoma
Basal Cell Carcinoma
Treatment
Combination cream of 5-fluorouracil and calcipotriene
5-fluorouracil cream
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 upclinic visits in addition to routine follow up visits
Participants may have multiple lesions enrolled in the study so long as theindividual lesions are greater than 2 cm from each other
If a woman is of childbearing potential, the participant must be willing to take apregnancy test before starting treatment and be on some form of birth control whilereceiving treatment. Birth control can include abstinence, oral contraceptive pill,intrauterine device, implanted birth control device, birth control patch, or thevaginal ring. The patient does not need to be on any form of birth control afterthey end therapy.
Exclusion
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
Study Design
Connect with a study center
Boston Medical Center Dermatology Clinic
Boston, Massachusetts 02118
United StatesActive - Recruiting
South Shore Health Center Dermatology Clinic
Quincy, Massachusetts 02169
United StatesSite Not Available
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