Effect of 5% potassium hydroxide solution versus cryotherapy on treatment of anogenital warts in men: a randomized clinical trial

To assess the effect of 5% potassium hydroxide solution versus cryotherapy on treatment of anogenital warts in men

This is a randomized clinical trial, phase III, in which 80 eligible patients will be randomly assigned to the intervention and control groups

The eligible men with anogenital warts referring to the Sina Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.

Inclusion criteria: Age of 18 to 75 years, Male anogenital warts, Exclusion criteria: Active skin wound or infection at the treatment site, Coagulation disorders, Immunodeficiency disorder, Any treatment for warts in the last 2 months, Cold intolerance, History of seizures

Intervention group: Rubbing topical 5% potassium hydroxide solution (manufactured by Avsina Co.)on the wart twice and then every two weeks up to 4 times Control group: Cryotherapy using liquid nitrogen (manufactured by Pishidad Gas Industrial Group) for 20 seconds on the wart twice and then every two weeks up to 4 times

Primary outcome: Wart diameter Secondary outcome: Side effects (pain, itching, burning, erythema, blister, scar, hypopigmentation, hyperpigmentation)

The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.