Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

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

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.

Study Overview

• Status: Unknown
• Conditions: Keratotic Nodular Size
• Intervention / Treatment: Drug: Tetracycline; Drug: Clotrimazole; Drug: Tetracycline and Clotrimazole; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Asiya Ferdous, MBBS; Phone Number: 01726693949; Email: aftrishna@gmail.com
• Study Contact Backup: Name: Wasi Azam, MBA; Phone Number: 01787675638; Email: wasidhaka@gmail.com

Study Locations

• Bangladesh
  • Laksham, Bangladesh, 3570
    • Recruiting
    • Eruain Community Clinic
    • Contact: Asiya Ferdous, MBBS; Phone Number: 01726693949; Email: aftrishna@gmail.com
    • Contact: Shahjalal, BA; Phone Number: 01920009497

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: Asiya Ferdous, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2018
• Primary Completion (Anticipated): October 30, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Keratosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole; Tetracycline
• Other Study ID Numbers: No.BSMMU/2018/924

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No