Recruiting
Early Phase 1

5-FU & Calcipotriene

Sponsor:

Carilion Clinic

Code:

NCT04839731

Conditions

Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream

Nourivan Base Cream

Study Details

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 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.

Conditions

Squamous Cell Carcinoma

Study ID

NCT04839731

Start date

Apr 14, 2021

Status verified date

Feb, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo group

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.

experimental: 7 day medication group

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

experimental: 14 day medication group

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

Interventions

Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream

Apply twice per day for allotted time

Nourivan Base Cream

Apply twice per day for allotted time

Primary outcome measure

  • Cancer resolution on histopathology [ Time Frame: 6-8 wks ]

Central Contacts and Locations

Central contacts

Kiley K Fagan, MD

5402245170kkfagan@carilionclinic.org

Mariana Phillips, MD

5405810170maphillips@carilionclinic.org

Locations

Carilion Clinic Dermatology and Mohs Surgery

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Kiley K Fagan, MD

540-224-5170kkfagan@carilionclinic.org

Mariana Phillips, MD

5405810170maphillips@carilionclinic.org

More Information

Sponsor

Carilion Clinic

Last update posted

Feb 13, 2023

Last verified

Feb, 2023

Keywords

  • Calcipotriene
  • Fluorouracil
  • Squamous cell carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2023-02-13.