Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream for Squamous Cell Carcinoma
Carilion Clinic Dermatology and Mohs Surgery, Roanoke, VA
Squamous Cell CarcinomaCombination topical 5-fluorouracil 5% / calcipotriene 0.005% cream - DrugStudy Summary
This trialwill test if combining two creams can treat skin cancer with fewer side effects and a shorter treatment duration.
Eligible Conditions
- Squamous Cell Carcinoma
Video Summary
Treatment Effectiveness
Phase-Based Effectiveness
Phase < 1
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 6-8 wks
3-4 wks
Cosmetic appearance
6-8 wks
Cancer resolution on histopathology
Final scar length
Trial Safety
Phase-Based Safety
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
3 Treatment Groups
14 day medication group
1 of 3
7 day medication group
1 of 3
Placebo group
1 of 3
Experimental Treatment
Non-Treatment Group
30 Total Participants · 3 Treatment Groups
Primary Treatment: Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream · Has Placebo Group · Phase < 1
14 day medication group
Drug
Experimental Group · 1 Intervention: Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream · Intervention Types: Drug7 day medication group
Drug
Experimental Group · 1 Intervention: Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream · Intervention Types: DrugPlacebo group
Drug
PlaceboComparator Group · 1 Intervention: Nourivan Base Cream · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-8 wks
Who is running the clinical trial?
Carilion ClinicLead Sponsor
67 Previous Clinical Trials
12,290 Total Patients Enrolled
Mariana Phillips, MDPrincipal InvestigatorCarilion Clinic Dermatology
1 Previous Clinical Trials
1,600 Total Patients Enrolled
Joshua D Eikenberg, MDPrincipal InvestigatorCarilion Clinic Dermatology
Eligibility Criteria
Age 18 - 100 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Cunningham, Trevor J., Mary Tabacchi, Jean-Pierre Eliane, Sara Moradi Tuchayi, Sindhu Manivasagam, Hengameh Mirzaalian, Ahu Turkoz, et al.. 2016. “Randomized Trial of Calcipotriol Combined with 5-fluorouracil for Skin Cancer Precursor Immunotherapy”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci89820.
- Cunningham, Trevor J., Mary Tabacchi, Jean-Pierre Eliane, Sara Moradi Tuchayi, Sindhu Manivasagam, Hengameh Mirzaalian, Ahu Turkoz, et al.. 2016. “Randomized Trial of Calcipotriol Combined with 5-fluorouracil for Skin Cancer Precursor Immunotherapy”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci89820.
- 2021. "Combination 5-FU / Calcipotriene Cream for SCCIS/SCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04839731.