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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03632733
Other study ID # No.BSMMU/2018/924
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 21, 2018
Est. completion date December 31, 2018

Study information

Verified date August 2018
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact Asiya Ferdous, MBBS
Phone 01726693949
Email aftrishna@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tetracycline
Tetracycline cream
Clotrimazole
Clotrimazole cream
Tetracycline and Clotrimazole
Combination cream
Other:
Placebo
Placebo cream without active drug ingredients

Locations

Country Name City State
Bangladesh Eruain Community Clinic Laksham

Sponsors (1)

Lead Sponsor Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in keratotic nodular size palmar arsenical keratosis will be measured before and after applying interventions three months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04693000 - Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis Phase 2
Recruiting NCT04608461 - Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis Phase 2
Recruiting NCT03641079 - Identification of Compound From Brinjal Peel Extract in the Treatment of Palmar Arsenical Keratosis and Bowen's Disease Phase 2
Recruiting NCT04686474 - Effect of the Compound Extracted From Azadirachta Indica Leaves in the Treatment of Arsenical Keratosis N/A
Recruiting NCT04686461 - Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis N/A