- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03127657
Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion
July 12, 2018 updated by: Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation injection and oral supplementation for osteoarthritis.
Hyaluronic acid acts as humectants and topical moisturizing agent to the skin due to excellent moisturizing property.
It has anti-inflammatory effect and used in the treatment of ulcer healing and to reduce the intensity of radioepithelitis.
It is also used as a topical vehicle for the delivery of drug to the skin in actinic keratosis.
In the case of arsenical keratotic nodule, topical application of hyaluronic acid may tends to decrease keratosis by repeated hydration of the skin.
Therefore, the study will be conducted to determine any beneficial effect of topical application of cock's comb extract in the treatment of the patients with severe palmar arsenical keratosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation injection and oral supplementation for osteoarthritis.
Hyaluronic acid is extensively utilized in many cosmetic products because of its moisturizing property as a topical moisturizing agent.
It is also used as dermal fillers for wrinkle correction.
It has anti-inflammatory effect and used in the treatment of different type of ulcers.
In case of acute radioepithelitis, 0.2% hyaluronic acid is used to reduce inflammation.
Hyaluronic acid has found important application in drug delivery system.
Recently 3% diclofenac in 2.5% hyaluronic acid gel has been approved for the treatment of actinic keratoses as a unique topical vehicle for the localized delivery of drug to the skin.
It is also used as a vehicle for various anticancer drugs.
As it has many effective topical applications, it can be used in arsenical keratosis.
In the case of arsenical keratotic nodule, topical application of hyaluronic acid may cause repeated hydration of the skin as a result keratosis tends to soften and disappear.
Therefore, the study will be conducted to identify the outcome of cock's comb extract in the treatment of arsenical skin lesion.
Biological activity and cytotoxicity of cock's comb extract have been identified after performing brine shrimp bioassay test.
Twenty-five patients with severe palmar (>5 mm) arsenical keratosis will be recruited on the basis of inclusion and exclusion criteria.
Before the study, water and nail samples will be collected to confirm arsenicosis.
Blood samples will be collected for liver and kidney function test to observe any adverse effects of topically applied cock's comb extract both before and after the study.
The cream will be prepared with 0.01% cock's comb extract mixed with olive oil, bee wax and benzoic acid for topical application 2 days prior visit of the recruited patients.
The patient will be applied the cream on the affected area with a clean fingertip by rubbing gently at twice daily for 12 weeks without any interruption.
Primary parameters will be the measurement of keratotic nodular size by slide calipers and perception scoring of the patients by Likert scale before and 12 weeks after the study.
Secondary parameters will be the measurement of arsenic level in drinking water and nails of the recruited patients.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Chandpur, Bangladesh, 3600
- Shahrashti
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: (Patients)
- Age: 18-60 years
- Sex: Both male and female
- Arsenical keratosis: Presence of severe keratosis (>5mm) in both palms
- Drinking arsenic contaminated water (>50 µg/L) for at least more than 6 months
- Patient voluntarily agreed to participate
- Patient who understood the instruction of applying drug and could apply drug as per as instruction
Exclusion Criteria:
- Age <18 and >60 years
- Pregnant and nursing mother
- Palmar psoriasis
- Eczema
- Any kind of systemic disease, inflammatory disease and infectious condition that affect skin for example diabetes mellitus, rheumatoid arthritis, systemic lupus erythrematosus, hepatitis
- Hypersensitivity to avain protein
- Malignancy
- Impaired renal function - if creatinine level >1.3 mg/dl incase of men and >1.1 mg/dl in case of women
- Patient who received any treatment of arsenicosis within last three months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cock's comb extract 0.01%
25 Patients Cock's comb extract 0.01% Applied topically twice daily for 12 weeks
|
Applied topically twice daily for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in palmer arsenical keratosis
Time Frame: [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: No]
|
Size of keratotic lesion will be decreased
|
[0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: No]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in arsenic level in nail
Time Frame: [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: Yes]
|
Arsenic level in nail will be decreased
|
[0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: Yes]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fatema Chowdhury, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2016
Primary Completion (Actual)
January 31, 2018
Study Completion (Actual)
January 31, 2018
Study Registration Dates
First Submitted
April 12, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (Actual)
April 25, 2017
Study Record Updates
Last Update Posted (Actual)
July 13, 2018
Last Update Submitted That Met QC Criteria
July 12, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSMMU-011-CT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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