A double-blind placebo-controlled study of 5-fluorouracil:cyclodextrin complex loaded thermosensitive gel for the treatment of HPV induced condyloma

Abstract

Objective of this double-blind placebo-controlled study was to determine the efficacy of thermosensitive mucoadhesive gel loaded with 5-fluorouracil (5-FU):hydroxypropyl-ß-cyclodextrin (HP-ß-CD) complex via topical administration or intralesional injection for the treatment of human papilloma virus induced condyloma in 44 women. The diagnosis of human papilloma virus was established with clinical, histopathological and polymerase chain reaction techniques. Subjects were randomized into four parallel groups to evaluate topical or intralesional administration of drug-loaded or blank gel. The formulation used in the study consisted of 20% Pluronic PF 127 and 0.2% hydroxypropylmethylcellulose (HPMC) to render thermosensitive and mucoadhesive properties to the blank and drug-loaded gels. 5-FU was complexed to hydroxypropyl-ß-cyclodextrin to improve its solubility and this complex was loaded into thermosensitive gel to obtain controlled release of the cytotoxic drug in administration site over a two-week period cure regimen aiming therapeutic efficacy with lower 5-FU doses. Complete response was achieved in 61% of patients through intralesional administration while topical administration resulted in only 29% complete cure. Relapse rates of all therapy groups were significantly low in the 6-month follow-up time.