Bangaru H, Mishra Shivani, Sachan Sonam S, Ramrakhiani Sonam
From the Department of Dermatology, Mysore Medical College and Research Institute and Associated Hospitals, K R Hospital, Mysore, Karnataka, India.
Consultant Dermatologists, Vighnaharta Multispeaciality Hospital, APMC Compound, Pachora Central, Pachora, Jalgaon, Maharashtra, India.
Indian J Dermatol. 2024 Nov-Dec;69(6):425-431. doi: 10.4103/ijd.ijd_636_23. Epub 2024 Oct 29.
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.
This is a prospective phase IV study to evaluate its safety and efficacy in the treatment of superficial epidermal and dermal lesions.
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.
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.
The data from this study support good clinical tolerability and safety of the Hydrozid portable cryo device.
冷冻手术在皮肤科实践中仍然是一种重要的治疗方式。HYDROZID是一种新型便携式冷冻手术医疗设备，使用诺氟烷作为制冷剂，最近已引入印度市场。本文报告了在印度进行的IV期研究结果。
这是一项前瞻性IV期研究，旨在评估其治疗浅表表皮和真皮病变的安全性和有效性。
该研究在印度的4个中心进行。冷冻手术周期根据所治疗的皮肤病变确定。在首次冷冻手术治疗后的第1天、第7天、第14天、第30天（±2天）（治疗结束时）和第60天（±2天）评估安全性和有效性参数。使用局部皮肤反应量表、疼痛视觉模拟量表以及用于评估色素沉着和瘢痕形成的温哥华量表来评估皮肤反应。通过在研究访视结束时评估皮肤病变的完全消失情况来评估疗效。
97名患者完成了研究。报告的术后疼痛为轻度至中度，并在24小时内消退。24小时结束时，84.76%的患者未观察到疼痛。研究结束时，47.4%的患者病变完全消失，而79.38%的患者皮肤病变直径缩小超过50%。
本研究数据支持HYDROZID便携式冷冻设备具有良好的临床耐受性和安全性。
