Abstract
BACKGROUND: Cryosurgery remains an important treatment modality in dermatology practice. HYDROZID(®), a new portable cryosurgery medical device using norflurane as a cryogen, was recently introduced in the Indian market. This paper reports the findings of the phase IV study conducted in India. AIMS: This is a prospective phase IV study to evaluate its safety and efficacy in the treatment of superficial epidermal and dermal lesions. METHODS: The study was conducted across 4 centres in India. The cryosurgery cycles were decided based on the skin lesion considered for the treatment. Safety and efficacy parameters were assessed at day 1, day 7, day 14, day 30 (±2) (end of treatment), and day 60 (±2) after the initial cryosurgery treatment. The local skin reactions scale, pain VAS scale, and Vancouver scale for assessment of pigmentation and scarring were used for the assessment of cutaneous reactions. Assessment of efficacy was done by evaluating the total disappearance of skin lesions at the end of the study visit. RESULTS: Ninety-seven patients completed the study. The reported post-procedural pain was mild to moderate and subsided over the period of 24 hours. There was no pain observed in 84.76% of patients at the end of 24 hours. Complete disappearance of the lesion was seen in 47.4% of patients at the end of the study, while the reduction in the diameter of skin lesions by more than 50% was observed in 79.38% of patients. CONCLUSION: The data from this study support good clinical tolerability and safety of the Hydrozid(®) portable cryo device.