Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2018
CompletedFirst Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedAugust 17, 2018
August 1, 2018
9 months
August 13, 2018
August 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in keratotic nodular size
palmar arsenical keratosis will be measured before and after applying interventions
three months
Study Arms (4)
Tetracycline group
ACTIVE COMPARATORTetracycline cream twice daily for three months
Clotrimazole group
ACTIVE COMPARATORClotrimazole cream twice daily for three months
Combination drug group
ACTIVE COMPARATORTetracycline and Clotrimazole combination cream twice daily for three months
Placebo group
PLACEBO COMPARATORparticipants will be provided a cream containing no active drug ingredients
Interventions
Combination cream
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eruain Community Clinic
Lākshām, 3570, Bangladesh
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asiya Ferdous, MBBS
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants are not aware of the drug they are given
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident, Department of Pharmacology, BSMMU
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 15, 2018
Study Start
January 21, 2018
Primary Completion
October 30, 2018
Study Completion
December 31, 2018
Last Updated
August 17, 2018
Record last verified: 2018-08