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临床试验/NCT03632733
NCT03632733Unknown2 期

Effects of Antimicrobials on the Altered Skin Flora in Patients With Palmar Arsenical Keratosis

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
30
试验地点
1
主要终点
Changes in keratotic nodular size

研究概览

简要总结

It had been found in certain studies that there is an alteration of normal skin flora in patients with arsenical keratosis. The relationship between such altered skin flora and development of keratosis in arsenicosis is not established or explored.There is no such study where effects of antimicrobials have been evaluated as the treatment of arsenical keratosis. So the present study is designed to see the effects of antimicrobials on the altered skin flora (Enterobacter and Aspergillus) in patients with palmar arsenical keratosis.

详细描述

According to a working group of World Health Organization, arsenicosis is a chronic health condition arising from prolonged ingestion (not less than six months) of arsenic above a safe level, usually manifested by characteristic and most diagnostic skin lesions, like- melanosis, leucomelanosis and keratosis, with or without involvement of internal organs. Arsenical keratosis usually appears on palm of the hand and plantar aspect of the feet and may also develop on the dorsum of the extremities and trunk. It had been found in certain studies that there is an alteration of normal skin flora in patients with arsenical keratosis. The relationship between such altered skin flora and development of keratosis in arsenicosis is not established or explored. Treatment of all types of keratosis is difficult. The most common therapeutic option leads to short-term improvement and is frequently associated with various adverse effects. Treatment tends to be symptomatic and includes topical keratolytic, orally administered antioxidant vitamins and minerals, or reconstructive surgery with total excision of the keratotic skin followed by grafting. There is no such study where effects of antimicrobials have been evaluated as the treatment of arsenical keratosis. So the present study is designed to see the effects of antimicrobials on the altered skin flora (Enterobacter and Aspergillus) in patients with palmar arsenical keratosis. The present study will be a clinical trial. The study will take place at the Department of Pharmacology, Department of Microbiology and Immunology of Bangabandhu Sheikh Mujib Medical University and at Laksham Upazilla of Comilla District from September 2017 to February 2019. After including participants as per selection criteria, written informed consent will be taken from all of them. Then water, nail, skin swab and scrapping samples will be collected and analyzed in the laboratory. After doing culture sensitivity, antimicrobials will be given to the patients. The duration of treatment will be decided upon sensitive drugs. Keratotic nodular size will be measured of each patient to draw a conclusion about the effect of antimicrobials in patients with palmar arsenical keratosis. As it had been found in previous studies conducted at the Department of Pharmacology of Bangabandhu Sheikh Mujib Medical University that both skin bacterial and fungal flora were altered in patients with arsenical keratosis, this study will be done to establish the relationship between such alteration and arsenical keratosis by exploring the effects of antimicrobials as a treatment of keratosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants are not aware of the drug they are given

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Drinking arsenic contaminated water (>50 microgram/ litre) for more than 6 months
  • Patient with moderate to severe arsenical palmar keratosis
  • Patient voluntarily agreed to participate
  • Patient did not receive topical application of any drug for the last three months
  • Patient who understood the instructions of applying drug and could apply drug as per as instructions -

排除标准

  • Patient who received any treatment of arsenicosis within last three months
  • Patient with diagnosed skin diseases, like- atopic dermatitis and psoriasis
  • Any diagnosed systemic diseases, inflammatory disease and infectious condition that affect the skin, for example- diabetes melitus, SLE and hepatitis

研究组 & 干预措施

Tetracycline group

Active Comparator

Tetracycline cream twice daily for three months

干预措施: Tetracycline (Drug)

Clotrimazole group

Active Comparator

Clotrimazole cream twice daily for three months

干预措施: Clotrimazole (Drug)

Combination drug group

Active Comparator

Tetracycline and Clotrimazole combination cream twice daily for three months

干预措施: Tetracycline and Clotrimazole (Drug)

Placebo group

Placebo Comparator

participants will be provided a cream containing no active drug ingredients

干预措施: Placebo (Other)

结局指标

主要结局

Changes in keratotic nodular size

时间窗: three months

palmar arsenical keratosis will be measured before and after applying interventions

次要结局

未报告次要终点

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asiya Ferdous

Resident, Department of Pharmacology, BSMMU

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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