A Phase 2 interventional study of Tetracycline and Clotrimazole in Keratotic Nodular Size, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Status unknown at 1 site in Bangladesh. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Phase 2, Interventional, and Treatment
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.
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.
348 studies on the registry are indexed under Keratosis; 13 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 294 interventional studies indexed under Keratosis.
Browse Keratosis studies →Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 126 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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Tetracycline cream twice daily for three months
Drug: Tetracycline
Clotrimazole cream twice daily for three months
Drug: Clotrimazole
Tetracycline and Clotrimazole combination cream twice daily for three months
Drug: Tetracycline and Clotrimazole
participants will be provided a cream containing no active drug ingredients
Other: Placebo
Tetracycline cream
Also known as: Tetrax
Clotrimazole cream
Also known as: Clotrim
Combination cream
Also known as: No other name
Placebo cream without active drug ingredients
Also known as: No other name
Changes in keratotic nodular size
palmar arsenical keratosis will be measured before and after applying interventions
Time frame: three months
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh