Combination Cream for Squamous Cell Carcinoma

Overseen By Mariana Phillips, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Carilion Clinic

Trial Summary

What is the purpose of this trial?

This trial tests if combining two creams can effectively treat certain skin cancers with minimal scarring and fewer side effects. It targets patients with specific types of squamous cell carcinoma on the trunk and upper extremities. The treatment works by boosting the immune system and directly killing cancer cells.

Research Team

Mariana Phillips, MD

Principal Investigator

Carilion Clinic Dermatology

Eligibility Criteria

Inclusion Criteria

Patient has capacity to provide consent

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

Exclusion Criteria

You cannot have surgery to remove something from your body due to a medical reason.

Your tumor has come back after previous treatment.

Contraindication to use of topical medication(s) (e.g., history of allergic contact dermatitis to topical 5-fluorouracil)

Treatment Details

Interventions

• 5-fluorouracil (Anti-metabolites)
• Excision (Other)
• Topical Cream (Other)

Participant Groups

Group I: 7 day medication group Experimental Treatment 1 Intervention

The 7 day medication group will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 7 days.

Group II: 14 day medication group Experimental Treatment 1 Intervention

The 14 day medication group will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 14 days.

Group III: Placebo group Placebo Group 1 Intervention

10 patients will be divided into 7 and 14 day treatment groups with 5 patients each. They will apply Nourivan base cream from Pure Science Rx, twice per day for their designated time.

5-fluorouracil is already approved in Canada, Japan for the following indications:

Approved in Canada as 5-FU for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer
• Esophageal cancer
• Anal cancer

Approved in Japan as 5-FU for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer
• Esophageal cancer
• Anal cancer

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+