Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-21

Study Completion Date

2018-12-31

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.

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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.

Conditions

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Keratotic Nodular Size

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three antimicrobials ( two single and one in combination form) and a placebo will be provided in patients randomly

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants are not aware of the drug they are given

Study Groups

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Tetracycline group

Tetracycline cream twice daily for three months

Group Type ACTIVE_COMPARATOR

Tetracycline

Intervention Type DRUG

Tetracycline cream

Clotrimazole group

Clotrimazole cream twice daily for three months

Group Type ACTIVE_COMPARATOR

Clotrimazole

Intervention Type DRUG

Clotrimazole cream

Combination drug group

Tetracycline and Clotrimazole combination cream twice daily for three months

Group Type ACTIVE_COMPARATOR

Tetracycline and Clotrimazole

Intervention Type DRUG

Combination cream

Placebo group

participants will be provided a cream containing no active drug ingredients

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo cream without active drug ingredients

Interventions

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Tetracycline

Tetracycline cream

Intervention Type DRUG

Clotrimazole

Clotrimazole cream

Intervention Type DRUG

Tetracycline and Clotrimazole

Combination cream

Intervention Type DRUG

Placebo

Placebo cream without active drug ingredients

Intervention Type OTHER

Other Intervention Names

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Tetrax Clotrim No other name No other name

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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No