Combination Topical 5-fluorouracil 5% / Calcipotriene 0.005% Cream for Treatment of in Situ and Superficially Invasive Squamous Cell Carcinoma of the Skin

IRB-19-691

The study will determine if calcipotriene and 5-fluorouracil (5-FU) creams when combined can treat SCCIS and superficially invasive SCC (but not deeply invasive or high-risk cutaneous SCC). 30 Patients will be divided into a 7 day treatment group (n=10), a 14 day treatment group (n=10), and a placebo group (n=10, divided into 7 and 14 days evenly). Following treatment with the topical chemotherapeutic medication, tumors would be completely excised according to standard of care, and specimens would be sent to pathology to determine if there was residual tumor/margin clearance. The potential benefit of this intervention would be the establishment of a non-invasive treatment that leads to minimal to no scarring or complications (akin to topical 5-FU alone) but would require a much shorter and more tolerable treatment duration (1-2 weeks) compared to available alternatives.

2021-04-14

2023-12-01

2023-12-01

Recruiting

Early phase I

30

Inclusion Criteria: * Recruited patients will be limited to those with a biopsy-proven in situ or superficially invasive (does not invade past the papillary dermis) squamous cell carcinoma of the skin of the low risk or "L" areas. The tumor must measure 1.0-2.0cm in longest diameter dimension. Tumors must lack induration and/or nodularity. The tumor must also demonstrate positive margins on review of the original biopsy pathology (biopsy must be partial; there must be residual tumor that requires further treatment). * Patient has capacity to provide consent Exclusion Criteria: * Immunocompromise or immunosuppression. * Contraindication to surgical excision. * Contraindication to use of topical medication(s) (e.g., history of allergic contact dermatitis to topical 5-fluorouracil) * Currently pregant, concerned could be pregnant, actively trying to conceive, or missed last menstrual period that is not explainable by birth control method (5-Fluorouracil is pregnancy category X) * Tumor is recurrent

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The three groups will include the following: Group 1 will be divided into 1- and 2-week treatment groups (5 patients in each group) and will apply placebo cream, Nourivan base cream from Pure Science Rx, twice per day for their designated time. Group 2 will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 7 days, and Group 3 will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 14 days. Patients will undergo randomization via an online randomization generator tool.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-02-13