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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03641079
Other study ID # No.BSMMU/2018/2961
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 16, 2017
Est. completion date February 2019

Study information

Verified date April 2018
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact Razia Sultana, MBBS
Phone 01715995605
Email dr.razia999@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date February 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Brinjal peel extract containing cream
Brinjal peel extract, white wax, white petrolatum, stearyl alcohol

Locations

Country Name City State
Bangladesh Faridpur Bhanga Hamirdi Community Clinic

Sponsors (1)

Lead Sponsor Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Keratotic nodular size and lesion size of Bowen's disease Nodular size and lesion size will be measured by slide calipers 12 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04693000 - Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis Phase 2
Recruiting NCT04608461 - Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis Phase 2
Recruiting NCT04686461 - Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis N/A
Recruiting NCT04686474 - Effect of the Compound Extracted From Azadirachta Indica Leaves in the Treatment of Arsenical Keratosis N/A
Recruiting NCT03632733 - Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis Phase 2