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Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

Primary Purpose

Keratotic Nodular Size

Status
Unknown status
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Tetracycline
Clotrimazole
Tetracycline and Clotrimazole
Placebo
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratotic Nodular Size

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Eruain Community ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Tetracycline group

Clotrimazole group

Combination drug group

Placebo group

Arm Description

Tetracycline cream twice daily for three months

Clotrimazole cream twice daily for three months

Tetracycline and Clotrimazole combination cream twice daily for three months

participants will be provided a cream containing no active drug ingredients

Outcomes

Primary Outcome Measures

Changes in keratotic nodular size
palmar arsenical keratosis will be measured before and after applying interventions

Secondary Outcome Measures

Full Information

First Posted
August 13, 2018
Last Updated
August 15, 2018
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT03632733
Brief Title
Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis
Official Title
Effects of Antimicrobials on the Altered Skin Flora in Patients With Palmar Arsenical Keratosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratotic Nodular Size

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Three antimicrobials ( two single and one in combination form) and a placebo will be provided in patients randomly
Masking
Participant
Masking Description
Participants are not aware of the drug they are given
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tetracycline group
Arm Type
Active Comparator
Arm Description
Tetracycline cream twice daily for three months
Arm Title
Clotrimazole group
Arm Type
Active Comparator
Arm Description
Clotrimazole cream twice daily for three months
Arm Title
Combination drug group
Arm Type
Active Comparator
Arm Description
Tetracycline and Clotrimazole combination cream twice daily for three months
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
participants will be provided a cream containing no active drug ingredients
Intervention Type
Drug
Intervention Name(s)
Tetracycline
Other Intervention Name(s)
Tetrax
Intervention Description
Tetracycline cream
Intervention Type
Drug
Intervention Name(s)
Clotrimazole
Other Intervention Name(s)
Clotrim
Intervention Description
Clotrimazole cream
Intervention Type
Drug
Intervention Name(s)
Tetracycline and Clotrimazole
Other Intervention Name(s)
No other name
Intervention Description
Combination cream
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
No other name
Intervention Description
Placebo cream without active drug ingredients
Primary Outcome Measure Information:
Title
Changes in keratotic nodular size
Description
palmar arsenical keratosis will be measured before and after applying interventions
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asiya Ferdous, MBBS
Phone
01726693949
Email
aftrishna@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wasi Azam, MBA
Phone
01787675638
Email
wasidhaka@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asiya Ferdous, MBBS
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eruain Community Clinic
City
Laksham
ZIP/Postal Code
3570
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asiya Ferdous, MBBS
Phone
01726693949
Email
aftrishna@gmail.com
First Name & Middle Initial & Last Name & Degree
Shahjalal, BA
Phone
01920009497

12. IPD Sharing Statement

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Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

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