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Trial record 47 of 201 for:    TETRACYCLINE

Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632733
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Asiya Ferdous, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date August 17, 2018
Actual Study Start Date  ICMJE January 21, 2018
Estimated Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
Changes in keratotic nodular size [ Time Frame: three months ]
palmar arsenical keratosis will be measured before and after applying interventions
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
Reduction of keratosis nodular size [ Time Frame: three months ]
palmar arsenical keratosis will be measured before and after applying interventions
Change History Complete list of historical versions of study NCT03632733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis
Official Title  ICMJE Effects of Antimicrobials on the Altered Skin Flora in Patients With Palmar Arsenical Keratosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Three antimicrobials ( two single and one in combination form) and a placebo will be provided in patients randomly
Masking: Single (Participant)
Masking Description:
Participants are not aware of the drug they are given
Primary Purpose: Treatment
Condition  ICMJE Keratotic Nodular Size
Intervention  ICMJE
  • Drug: Tetracycline
    Tetracycline cream
    Other Name: Tetrax
  • Drug: Clotrimazole
    Clotrimazole cream
    Other Name: Clotrim
  • Drug: Tetracycline and Clotrimazole
    Combination cream
    Other Name: No other name
  • Other: Placebo
    Placebo cream without active drug ingredients
    Other Name: No other name
Study Arms  ICMJE
  • Active Comparator: Tetracycline group
    Tetracycline cream twice daily for three months
    Intervention: Drug: Tetracycline
  • Active Comparator: Clotrimazole group
    Clotrimazole cream twice daily for three months
    Intervention: Drug: Clotrimazole
  • Active Comparator: Combination drug group
    Tetracycline and Clotrimazole combination cream twice daily for three months
    Intervention: Drug: Tetracycline and Clotrimazole
  • Placebo Comparator: Placebo group
    participants will be provided a cream containing no active drug ingredients
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Asiya Ferdous, MBBS 01726693949 aftrishna@gmail.com
Contact: Wasi Azam, MBA 01787675638 wasidhaka@gmail.com
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03632733
Other Study ID Numbers  ICMJE No.BSMMU/2018/924
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asiya Ferdous, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Sponsor  ICMJE Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Asiya Ferdous, MBBS Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
PRS Account Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP