Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Tetracycline group Tetracycline cream twice daily for three months |
Drug: Tetracycline
Tetracycline cream
Other Names:
|
| Active Comparator: Clotrimazole group Clotrimazole cream twice daily for three months |
Drug: Clotrimazole
Clotrimazole cream
Other Names:
|
| Active Comparator: Combination drug group Tetracycline and Clotrimazole combination cream twice daily for three months |
Drug: Tetracycline and Clotrimazole
Combination cream
Other Names:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Changes in keratotic nodular size [three months]
palmar arsenical keratosis will be measured before and after applying interventions
Eligibility Criteria
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
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eruain Community Clinic | Laksham | Bangladesh | 3570 |
Sponsors and Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
- Principal Investigator: Asiya Ferdous, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- No.BSMMU/2018/924