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Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion

Primary Purpose

Chronic Arsenic Poisoning

Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Cock's comb extract 0.01%
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Arsenic Poisoning

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shahrashti

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cock's comb extract 0.01%

Arm Description

25 Patients Cock's comb extract 0.01% Applied topically twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Changes in palmer arsenical keratosis
Size of keratotic lesion will be decreased

Secondary Outcome Measures

Changes in arsenic level in nail
Arsenic level in nail will be decreased

Full Information

First Posted
April 12, 2017
Last Updated
July 12, 2018
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT03127657
Brief Title
Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion
Official Title
Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 17, 2016 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Arsenic Poisoning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Topical application of cock's comb extract in the treatment of palmar arsenical keratosis
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cock's comb extract 0.01%
Arm Type
Experimental
Arm Description
25 Patients Cock's comb extract 0.01% Applied topically twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Cock's comb extract 0.01%
Other Intervention Name(s)
Cock's comb extract cream
Intervention Description
Applied topically twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Changes in palmer arsenical keratosis
Description
Size of keratotic lesion will be decreased
Time Frame
[0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: No]
Secondary Outcome Measure Information:
Title
Changes in arsenic level in nail
Description
Arsenic level in nail will be decreased
Time Frame
[0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: Yes]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatema Chowdhury, MBBS
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahrashti
City
Chandpur
ZIP/Postal Code
3600
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion

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