5-Fluorouracil and Calcipotriene Cream for Superficial Skin Cancers
This study evaluates the effectiveness of combining 5-Fluorouracil and Calcipotriene cream to treat and clear superficial skin cancers in patients over a period of three months and three years.
Combination cream of 5-fluorouracil and calcipotriene
+ 5-fluorouracil cream
Squamous Intraepithelial Lesions
+ Pathological Conditions, Signs and Symptoms
+ Morphological and Microscopic Findings
Treatment Study
Summary
Study start date: October 15, 2022
Actual date on which the first participant was enrolled.This study explores a new treatment method for low-risk skin cancers, specifically superficial basal cell carcinoma and squamous cell carcinoma in situ. The aim is to evaluate how effective a combination of two creams, 5-Fluorouracil and Calcipotriene, is at treating these skin cancers. 5-Fluorouracil is already used for these conditions, but the study is testing a new combination cream that has been effective in preventing other pre-cancerous skin conditions. This study is significant because it might offer a shorter and potentially more effective treatment option for patients with these types of skin cancer. Participants will apply the combination cream for 7 to 14 days. The study will monitor whether this shorter treatment duration can clear the cancer lesions effectively. Dermatologists will assess the lesions to determine if the cancer is gone, using standard clinical assessments and photographs. Participants will be followed up for three years, with regular check-ups every six months to ensure the cancer does not return. If necessary, further biopsies will be conducted to confirm the results. The main goal is to see if the cancer lesions are fully cleared at both three months and three years after treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * English-speaking * Having a previously untreated, biopsy-proven Superficial Basal Cell Carcinoma (sBCC) or Squamous Cell Carcinoma in Situ (SCCis) of the skin \<2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia * Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates * Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits * Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other * If a woman is of childbearing potential, the participant must be willing to take a pregnancy test before starting treatment and be on some form of birth control while receiving treatment. Birth control can include abstinence, oral contraceptive pill, intrauterine device, implanted birth control device, birth control patch, or the vaginal ring. The patient does not need to be on any form of birth control after they end therapy. Exclusion Criteria: * Current or prior field treatment within 2 cm of the target BCC or SCCis * Periorbital lesions * Lesions that have been previously treated * Known allergy to any of the study medication ingredients * History of solid organ transplant or current immunosuppression * Genetic disorders associated with high skin cancer risk * Arsenic exposure * Cutaneous T-cell lymphoma * Current or prior radiation therapy at the site of the sBCC or SCCis * Women who are pregnant or currently breastfeeding * Prior psoralen plus Ultraviolet light (UVA) treatment at the site * Very high mortality risk at the start of the study * Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency * Demonstrated hypercalcemia or evidence of vitamin D toxicity * Lesions that extend into the oral, nasal or genital mucosa
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Boston Medical Center Dermatology Clinic
Boston, United StatesOpen Boston Medical Center Dermatology Clinic in Google Maps