Keratotic Nodular SizePhase 2NCT03641079
Identification of Compound From Brinjal Peel Extract in the Treatment of Palmar Arsenical Keratosis and Bowen's Disease
A Phase 2 study testing Brinjal peel extract containing cream in people with Keratotic Nodular Size, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Keratotic Nodular Size
- What is being tested?
- Brinjal peel extract containing cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBangladesh
- Study dates
- 16 Sep 2017to Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of severe keratosis and/or Bowen's disease
- Drinking arsenic contaminated water for at least six months
- Patient voluntarily agreed to participate
Who cannot join
- Age less than 18 years or more than 60 years
- Pregnant and nursing mother
- Skin diseases like atopic dermatitis, eczema and psoriasis
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Faridpur
Bhanga, Hamirdi Community Clinic, 7830
Razia Sultana, MBBS, 01715995605, dr.razia999@gmail.com
Shafiq Rahman, 01762262836
About this study
Official title: Identification of Compound From Brinjal Peel Extract That is Effective in the Treatment of Severe Palmar Arsenical Keratosis and Bowen's Disease
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.
Read the 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.
- Conditions
- Keratotic Nodular Size
- Being tested
- Brinjal peel extract containing cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brinjal peel extract containing creamDrug
Brinjal peel extract, white wax, white petrolatum, stearyl alcohol
| Study group | Role | What they receive |
|---|---|---|
| brinjal peel extract containing cream | Experimental | intervention-brinjal peel extract containing cream, dose-twice daily for 12 weeks Receives: Drug: Brinjal peel extract containing cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratotic nodular size and lesion size of Bowen's disease
Nodular size and lesion size will be measured by slide calipers
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start16 Sep 2017
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratotic Nodular SizeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Razia Sultana, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Razia Sultana, MBBS, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641079
- Sponsor's protocol ID
- No.BSMMU/2018/2961
- Status last verified
- Apr 2018
- First submitted
- 18 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Compound From Brinjal Peel Extract That is Effective in the Treatment of Severe Palmar Arsenical Keratosis and Bowen's Disease
- ClinicalTrials.gov ID
- NCT03641079
- Acronym / sponsor ID
- No.BSMMU/2018/2961
- Conditions
- Keratotic Nodular Size
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 16 Sep 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brinjal peel extract containing cream | Experimental | Drug: Brinjal peel extract containing creamintervention-brinjal peel extract containing cream, dose-twice daily for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of severe keratosis and/or Bowen's disease
- Drinking arsenic contaminated water for at least six months
- Patient voluntarily agreed to participate
Key exclusion criteria (3 listed)
- Age less than 18 years or more than 60 years
- Pregnant and nursing mother
- Skin diseases like atopic dermatitis, eczema and psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brinjal peel extract containing creamBrinjal peel extract, white wax, white petrolatum, stearyl alcohol | Drug | brinjal peel extract containing cream |
Primary outcome
Keratotic nodular size and lesion size of Bowen's disease
Time frame: 12 weeks
Nodular size and lesion size will be measured by slide calipers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Razia Sultana, MBBS principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brinjal peel extract containing cream in people with Keratotic Nodular Size, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Razia Sultana, MBBS (01715995605, dr.razia999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratotic nodular size and lesion size of Bowen's disease (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.