BACKGROUND: In certain situations, successful topical therapy of basal cell carcinoma (BCC) without the inconvenience, risk, and expense of surgery would be of great value to patients. Placing 5-fluorouracil (FU) in an appropriate carrier may solve these problems. Phosphatidyl choline (PC) penetrates effectively throughout the epidermis of shaved rabbits and may be able to carry small water-soluble molecules such as nucleotides across lipid barriers when applied topically. OBJECTIVE: We propose that employing PC as a vehicle will facilitate the penetration of 5-FU and increase efficacy as compared to petrolatum-based 5-FUcream. METHODS: This pilot study is a double-blinded and randomized therapeutic trial. Thirteen patients with 17 biopsy-proven, moderate thickness BCCs were randomized to receive either cream A (5% 5-FU in a PC vehicle) or cream B (Efudex(R): 5% 5-FU in a petrolatum base). Patients applied cream A or cream B twice a day for 4 weeks. The patients underwent an excisional biopsy of the treated BCC site at week 16. RESULTS: There was a 90% cure rate (9/10) in those lesions treated with 5% 5-FU in PC cream and a 57% cure rate (4/7) in those treated with 5% 5-FU in a petrolatum-based cream. CONCLUSION: Although the study was unable to detect any statistically significant differences in outcome between the study groups, this small pilot study shows preliminary findings which may indicate an increase in the short-term eradication of BCC using a PC-based vehicle as compared to conventional petrolatum-based formulations.
RCT Entities:
BACKGROUND: In certain situations, successful topical therapy of basal cell carcinoma (BCC) without the inconvenience, risk, and expense of surgery would be of great value to patients. Placing 5-fluorouracil (FU) in an appropriate carrier may solve these problems. Phosphatidyl choline (PC) penetrates effectively throughout the epidermis of shaved rabbits and may be able to carry small water-soluble molecules such as nucleotides across lipid barriers when applied topically. OBJECTIVE: We propose that employing PC as a vehicle will facilitate the penetration of 5-FU and increase efficacy as compared to petrolatum-based 5-FU cream. METHODS: This pilot study is a double-blinded and randomized therapeutic trial. Thirteen patients with 17 biopsy-proven, moderate thickness BCCs were randomized to receive either cream A (5% 5-FU in a PC vehicle) or cream B (Efudex(R): 5% 5-FU in a petrolatum base). Patients applied cream A or cream B twice a day for 4 weeks. The patients underwent an excisional biopsy of the treated BCC site at week 16. RESULTS: There was a 90% cure rate (9/10) in those lesions treated with 5% 5-FU in PC cream and a 57% cure rate (4/7) in those treated with 5% 5-FU in a petrolatum-based cream. CONCLUSION: Although the study was unable to detect any statistically significant differences in outcome between the study groups, this small pilot study shows preliminary findings which may indicate an increase in the short-term eradication of BCC using a PC-based vehicle as compared to conventional petrolatum-based formulations.