Identification of Compound From Brinjal Peel Extract in the Treatment of Palmar Arsenical Keratosis and Bowen's Disease
Primary Purpose
Keratotic Nodular Size
Status
Unknown status
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Brinjal peel extract containing cream
Sponsored by
About this trial
This is an interventional treatment trial for Keratotic Nodular Size
Eligibility Criteria
Inclusion Criteria:
- Presence of severe keratosis and/or Bowen's disease
- Drinking arsenic contaminated water for at least six months
- Patient voluntarily agreed to participate
Exclusion Criteria:
- Age less than 18 years or more than 60 years
- Pregnant and nursing mother
- Skin diseases like atopic dermatitis, eczema and psoriasis
Sites / Locations
- FaridpurRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
brinjal peel extract containing cream
Arm Description
intervention-brinjal peel extract containing cream, dose-twice daily for 12 weeks
Outcomes
Primary Outcome Measures
Keratotic nodular size and lesion size of Bowen's disease
Nodular size and lesion size will be measured by slide calipers
Secondary Outcome Measures
Full Information
NCT ID
NCT03641079
First Posted
August 18, 2018
Last Updated
August 18, 2018
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT03641079
Brief Title
Identification of Compound From Brinjal Peel Extract in the Treatment of Palmar Arsenical Keratosis and Bowen's Disease
Official Title
Identification of Compound From Brinjal Peel Extract That is Effective in the Treatment of Severe Palmar Arsenical Keratosis and Bowen's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
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
Arsenicosis is a major health problem in Bangladesh. Long term exposure of arsenic causes keratosis of palm which reduce working capacity of patient. It also causes invasive skin lesions like Bowen's disease which has a risk to develop squamous cell carcinoma. Brinjal peel is well known for its antioxidant and anticancer properties. So this study will be conducted to identify the compound from brinjal peel extract and to see its outcome on keratosis and Bowen's disease.
Detailed Description
Arsenicosis is a major health problem in Bangladesh. About half of the population are chronically exposed to high concentration of arsenic through contaminated drinking water. In arsenicosis, keratosis of palm and sole occur which reduce the working capacity of the patient and affect the socioeconomic condition. It also causes invasive skin lesions like Bowen's disease, squamous cell carcinoma, and basal cell carcinoma. Bowen's disease usually appears as a persistent reddened scaly patch on the skin and has a risk (3-5%) to develop squamous cell carcinoma. Keratosis can be treated by different topical preparations like salicylic acid, propylene glycol and oral antioxidant, zinc and folic acid, but treatment by these medicines require a longer time to relieve and thus reduce patient's compliance. On the other hand, treatment options available for Bowen's disease are expensive. Brinjal is a common vegetable which contains steroidal alkaloids, steroidal glycosides, delphinidine, nasunin and other biologically active compounds. These biologically active compounds are effective against human cancer cells by various mechanisms. One study shows that a topical cream prepared from brinjal peel extract is effective in keratosis and skin carcinoma. So, this study will be conducted to see the outcome of brinjal peel extract in severe palmar arsenical keratosis and Bowen's disease and to identify the compound that is responsible for the effect. The study will be an Open Phase- II Clinical Trial. It will be conducted in Bangabandhu Sheikh Mujib Medical University and Bhanga Upazilla of Faridpur District. Extracts from brinjal peel will be collected by using a mixture of ethanol, chloroform and acetic acid as a solvent in Soxhlet extractor and rotary evaporator. Thin Layer Chromatography (TLC), Nuclear Magnetic Resonance (NMR) and Infrared (IR) of extract will be done to identify compound. Cytotoxicity assay will be done by using brine shrimp bioassay. Then a topical cream will be prepared from the extract and supplied at the field level through a temporary arsenic clinic at an interval of two weeks. Instruction will be given to the patients about applying the cream. Adherence and adverse effects of the cream will be monitored regularly through phone calls and during each visit. Photograph will be taken and size of the keratotic nodules as well as, lesions of Bowen's disease will be measured before the start and after completion of treatment. Clinical improvement will be assessed by the mean scoring of nodules and lesions and perception of patients about their improvement by using Likert Scale. Statistical analysis and results will be presented in tabulated forms and in different diagrams.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratotic Nodular Size
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
brinjal peel extract containing cream
Arm Type
Experimental
Arm Description
intervention-brinjal peel extract containing cream, dose-twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Brinjal peel extract containing cream
Intervention Description
Brinjal peel extract, white wax, white petrolatum, stearyl alcohol
Primary Outcome Measure Information:
Title
Keratotic nodular size and lesion size of Bowen's disease
Description
Nodular size and lesion size will be measured by slide calipers
Time Frame
12 weeks
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:
Presence of severe keratosis and/or Bowen's disease
Drinking arsenic contaminated water for at least six months
Patient voluntarily agreed to participate
Exclusion Criteria:
Age less than 18 years or more than 60 years
Pregnant and nursing mother
Skin diseases like atopic dermatitis, eczema and psoriasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Razia Sultana, MBBS
Phone
01715995605
Email
dr.razia999@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraful Islam, MBBS
Phone
01715995605
Email
dr.ashraf999@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Razia Sultana, MBBS
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faridpur
City
Bhanga
State/Province
Hamirdi Community Clinic
ZIP/Postal Code
7830
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Razia Sultana, MBBS
Phone
01715995605
Email
dr.razia999@gmail.com
First Name & Middle Initial & Last Name & Degree
Shafiq Rahman
Phone
01762262836
12. IPD Sharing Statement
Learn more about this trial
Identification of Compound From Brinjal Peel Extract in the Treatment of Palmar Arsenical Keratosis and Bowen's Disease
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