Status:
UNKNOWN
Combination 5-FU / Calcipotriene Cream for SCCIS/SCC
Lead Sponsor:
Carilion Clinic
Conditions:
Squamous Cell Carcinoma
Eligibility:
All Genders
18-100 years
Phase:
EARLY_PHASE1
Brief Summary
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 Patient...
Detailed Description
Squamous cell carcinoma (SCC) of the skin is exceedingly common. For the most part, cutaneous SCC grows slowly and has a very high cure rate with excision for deep tumors or mechanical/chemical destru...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04839731
Start Date
April 14 2021
End Date
December 1 2023
Last Update
February 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Carilion Clinic Dermatology and Mohs Surgery
Roanoke, Virginia, United States, 24016