Skip to content

Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

Effects of Antimicrobials on the Altered Skin Flora in Patients With Palmar Arsenical Keratosis

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03632733
Enrollment
30
Registered
2018-08-15
Start date
2018-01-21
Completion date
2018-12-31
Last updated
2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratotic Nodular Size

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.

Interventions

DRUGTetracycline

Tetracycline cream

Clotrimazole cream

DRUGTetracycline and Clotrimazole

Combination cream

OTHERPlacebo

Placebo cream without active drug ingredients

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants are not aware of the drug they are given

Intervention model description

Three antimicrobials ( two single and one in combination form) and a placebo will be provided in patients randomly

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Changes in keratotic nodular sizethree monthspalmar arsenical keratosis will be measured before and after applying interventions

Countries

Bangladesh

Contacts

Primary ContactAsiya Ferdous, MBBS
aftrishna@gmail.com01726693949
Backup ContactWasi Azam, MBA
wasidhaka@gmail.com01787675638

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026