Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Keratotic Nodular Size

Intervention / Treatment
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* Drug: Tetracycline
* Drug: Clotrimazole
* Drug: Tetracycline and Clotrimazole
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 - Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three antimicrobials ( two single and one in combination form) and a placebo will be provided in patients randomly
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tetracycline group<br>Tetracycline cream twice daily for three months | Drug: Tetracycline<br>* Tetracycline cream<br>* Other names: Tetrax;|
| Active Comparator: Clotrimazole group<br>Clotrimazole cream twice daily for three months | Drug: Clotrimazole<br>* Clotrimazole cream<br>* Other names: Clotrim;|
| Active Comparator: Combination drug group<br>Tetracycline and Clotrimazole combination cream twice daily for three months | Drug: Tetracycline and Clotrimazole<br>* Combination cream<br>* Other names: No other name;|
| Placebo Comparator: Placebo group<br>participants will be provided a cream containing no active drug ingredients | Other: Placebo<br>* Placebo cream without active drug ingredients<br>* Other names: No other name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in keratotic nodular size | palmar arsenical keratosis will be measured before and after applying interventions | three months |