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Trial record 32 of 40 for:    Clotrimazole

Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

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ClinicalTrials.gov Identifier: NCT03632733
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Asiya Ferdous, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Keratotic Nodular Size Drug: Tetracycline Drug: Clotrimazole Drug: Tetracycline and Clotrimazole Other: Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three antimicrobials ( two single and one in combination form) and a placebo will be provided in patients randomly
Masking: Single (Participant)
Masking Description: Participants are not aware of the drug they are given
Primary Purpose: Treatment
Official Title: Effects of Antimicrobials on the Altered Skin Flora in Patients With Palmar Arsenical Keratosis
Actual Study Start Date : January 21, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Tetracycline group
Tetracycline cream twice daily for three months
Drug: Tetracycline
Tetracycline cream
Other Name: Tetrax

Active Comparator: Clotrimazole group
Clotrimazole cream twice daily for three months
Drug: Clotrimazole
Clotrimazole cream
Other Name: Clotrim

Active Comparator: Combination drug group
Tetracycline and Clotrimazole combination cream twice daily for three months
Drug: Tetracycline and Clotrimazole
Combination cream
Other Name: 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 Name: No other name




Primary Outcome Measures :
  1. Changes in keratotic nodular size [ Time Frame: three months ]
    palmar arsenical keratosis will be measured before and after applying interventions



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632733


Contacts
Contact: Asiya Ferdous, MBBS 01726693949 aftrishna@gmail.com
Contact: Wasi Azam, MBA 01787675638 wasidhaka@gmail.com

Locations
Bangladesh
Eruain Community Clinic Recruiting
Laksham, Bangladesh, 3570
Contact: Asiya Ferdous, MBBS    01726693949    aftrishna@gmail.com   
Contact: Shahjalal , BA    01920009497      
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
Principal Investigator: Asiya Ferdous, MBBS Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Responsible Party: Asiya Ferdous, Resident, Department of Pharmacology, BSMMU, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03632733     History of Changes
Other Study ID Numbers: No.BSMMU/2018/924
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
Keratosis
Skin Diseases
Anti-Infective Agents
Tetracycline
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action