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临床试验/CTRI/2020/04/024710
CTRI/2020/04/024710已完成3 期

A COMPARATIVE STUDY OF FRACTIONAL CO2 LASER VERSUS Q-SWITCHED ND-YAG LASER IN THE MANAGEMENT OF ONYCHOMYCOSIS

COMMAND HOSPITAL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年4月20日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
TREATMENT OF NAIL FUNGAL INFECTION-l)Follow-up shall be performed at each visit at 4 weeks interval with assessment of clinical improvement using OSI score, photography and patient subjective assessment score. In addition to the above modalities, assessment will be done with mycological cultures and KOH mount after 16 weeks and 6 months from initiation of treatment. Analysis of the data will be carried out at 6 months after initiation of treatment .

研究概览

简要总结

study will be comparing the efficacy and side effect profile of Fractional CO2 LASER as compared to ,Nd-YAG LASER which is an accepted modality of treatment   for onychomycosis.For the above study three passes of each laser will be given to two different diseased nail on each sitting , and result will be compared after 6weeks, and 16 weeks of treatment

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • a)All consecutive patients over the age of 18 years of either gender reporting to the department of Dermatology, CHAF Bangalore with one or more toenail and/or fingernail fungal infections of the following types: distal subungual onychomycosis, proximal subungual onychomycosis, superficial white or black onychomycosis, mixed patterns or total dystrophic type onychomycosis.
  • b)Diagnosis of Onychomycosis confirmed on demonstration of fungal hyphae on direct microscopy or fungal culture.
  • c)Subjects should be willing and able to comply with all follow-up requirements d)Not on any medication for past 06 months for Onychomycosis.

排除标准

  • a)Cases where KOH mount for fungal hyphae and fungal culture are negative.
  • b)Patients who were on systemic or topical antifungals in the past three months.
  • c)Nail disorders due to psoriasis, chronic eczema, lichen planus, bacterial infections, subungual hematoma, and non-onychomycosis causes of nail dystrophy.
  • d)Pregnant and lactating women.

结局指标

主要结局

TREATMENT OF NAIL FUNGAL INFECTION-l)Follow-up shall be performed at each visit at 4 weeks interval with assessment of clinical improvement using OSI score, photography and patient subjective assessment score. In addition to the above modalities, assessment will be done with mycological cultures and KOH mount after 16 weeks and 6 months from initiation of treatment. Analysis of the data will be carried out at 6 months after initiation of treatment .

时间窗: After 6weeks and 6 month of 1st sitting of laser treatment.

次要结局

  • REDUCTION IN QSI SCORE(16 weeks and 6 months from initiation of treatment)

研究者

发起方
COMMAND HOSPITAL
申办方类型
Research institution and hospital

研究点 (1)

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