Keratotic Nodular SizePhase 2NCT03632733
Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis
A Phase 2 study testing Tetracycline, Clotrimazole and Tetracycline and Clotrimazole in people with Keratotic Nodular Size, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Keratotic Nodular Size
- What is being tested?
- Tetracycline, Clotrimazole and Tetracycline and Clotrimazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBangladesh
- Study dates
- 21 Jan 2018to 31 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Eruain Community Clinic
Lākshām, 3570
Asiya Ferdous, MBBS, 01726693949, aftrishna@gmail.com
Shahjalal, BA, 01920009497
About this study
Official title: Effects of Antimicrobials on the Altered Skin Flora in Patients With Palmar Arsenical Keratosis
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.
Read the 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.
- Conditions
- Keratotic Nodular Size
- Being tested
- Tetracycline, Clotrimazole, Tetracycline and Clotrimazole, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracyclineDrug
Also called Tetrax
Tetracycline cream
ClotrimazoleDrug
Also called Clotrim
Clotrimazole cream
Tetracycline and ClotrimazoleDrug
Also called No other name
Combination cream
PlaceboOther
Also called No other name
Placebo cream without active drug ingredients
| Study group | Role | What they receive |
|---|---|---|
| Tetracycline group | Active comparator | Tetracycline cream twice daily for three months Receives: Drug: Tetracycline |
| Clotrimazole group | Active comparator | Clotrimazole cream twice daily for three months Receives: Drug: Clotrimazole |
| Combination drug group | Active comparator | Tetracycline and Clotrimazole combination cream twice daily for three months Receives: Drug: Tetracycline and Clotrimazole |
| Placebo group | Placebo comparator | participants will be provided a cream containing no active drug ingredients Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in keratotic nodular size
palmar arsenical keratosis will be measured before and after applying interventions
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start21 Jan 2018
- Primary completion30 Oct 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratotic Nodular SizeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three antimicrobials ( two single and one in combination form) and a placebo will be provided in patients randomly
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asiya Ferdous, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Asiya Ferdous, MBBS, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632733
- Sponsor's protocol ID
- No.BSMMU/2018/924
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antimicrobials on the Altered Skin Flora in Patients With Palmar Arsenical Keratosis
- ClinicalTrials.gov ID
- NCT03632733
- Acronym / sponsor ID
- No.BSMMU/2018/924
- Conditions
- Keratotic Nodular Size
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Three antimicrobials ( two single and one in combination form) and a placebo will be provided in patients randomly
| Arm | Type | Receives |
|---|---|---|
| Tetracycline group | Active comparator | Drug: TetracyclineTetracycline cream twice daily for three months |
| Clotrimazole group | Active comparator | Drug: ClotrimazoleClotrimazole cream twice daily for three months |
| Combination drug group | Active comparator | Drug: Tetracycline and ClotrimazoleTetracycline and Clotrimazole combination cream twice daily for three months |
| Placebo group | Placebo comparator | Other: Placeboparticipants will be provided a cream containing no active drug ingredients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetracyclineAlso: TetraxTetracycline cream | Drug | Tetracycline group |
| ClotrimazoleAlso: ClotrimClotrimazole cream | Drug | Clotrimazole group |
| Tetracycline and ClotrimazoleAlso: No other nameCombination cream | Drug | Combination drug group |
| PlaceboAlso: No other namePlacebo cream without active drug ingredients | Other | Placebo group |
Primary outcome
Changes in keratotic nodular size
Time frame: three months
palmar arsenical keratosis will be measured before and after applying interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asiya Ferdous, MBBS principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tetracycline, Clotrimazole and Tetracycline and Clotrimazole in people with Keratotic Nodular Size, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asiya Ferdous, MBBS (01726693949, aftrishna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in keratotic nodular size (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.