Identification of Compound From Brinjal Peel Extract in the Treatment of Palmar Arsenical Keratosis and Bowen's Disease
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2017
CompletedFirst Submitted
Initial submission to the registry
August 18, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedAugust 21, 2018
April 1, 2018
1.2 years
August 18, 2018
August 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Keratotic nodular size and lesion size of Bowen's disease
Nodular size and lesion size will be measured by slide calipers
12 weeks
Study Arms (1)
brinjal peel extract containing cream
EXPERIMENTALintervention-brinjal peel extract containing cream, dose-twice daily for 12 weeks
Interventions
Brinjal peel extract, white wax, white petrolatum, stearyl alcohol
Eligibility Criteria
You may qualify if:
- Presence of severe keratosis and/or Bowen's disease
- Drinking arsenic contaminated water for at least six months
- Patient voluntarily agreed to participate
You may not qualify if:
- Age less than 18 years or more than 60 years
- Pregnant and nursing mother
- Skin diseases like atopic dermatitis, eczema and psoriasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faridpur
Bhanga, Hamirdi Community Clinic, 7830, Bangladesh
Study Officials
- PRINCIPAL INVESTIGATOR
Razia Sultana, MBBS
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
August 18, 2018
First Posted
August 21, 2018
Study Start
September 16, 2017
Primary Completion
December 1, 2018
Study Completion
February 1, 2019
Last Updated
August 21, 2018
Record last verified: 2018-04