## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** No.BSMMU/2018/2961
#### Organization
**Class:** OTHER
**Full Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
### Status Module
#### Completion Date
**Date:** 2019-02

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2018-08-21

**Type:** ACTUAL

**Last Update Submit Date:** 2018-08-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2018-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-09-16

**Type:** ACTUAL

**Status Verified Date:** 2018-04

#### Study First Post Date
**Date:** 2018-08-21
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-18
**Study First Submit QC Date:** 2018-08-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

#### Responsible Party

**Investigator Affiliation:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

**Investigator Full Name:** Dr. Razia Sultana

**Investigator Title:** Resident

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Keratotic Nodular Size

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** intervention-brinjal peel extract containing cream, dose-twice daily for 12 weeks

**Intervention Names:**

- Drug: Brinjal peel extract containing cream

**Label:** brinjal peel extract containing cream

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- brinjal peel extract containing cream

**Description:** Brinjal peel extract, white wax, white petrolatum, stearyl alcohol

**Name:** Brinjal peel extract containing cream

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Nodular size and lesion size will be measured by slide calipers

**Measure:** Keratotic nodular size and lesion size of Bowen's disease

**Time Frame:** 12 weeks

### Eligibility Module

**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

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dr.razia999@gmail.com

**Name:** Razia Sultana, MBBS

**Phone:** 01715995605

**Role:** CONTACT

**Contact 2:**

**Email:** dr.ashraf999@gmail.com

**Name:** Ashraful Islam, MBBS

**Phone:** 01715995605

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bhanga

**Contacts:**

***Contact 1:***

- **Email:** dr.razia999@gmail.com

- **Name:** Razia Sultana, MBBS

- **Phone:** 01715995605

- **Role:** CONTACT

***Contact 2:***

- **Name:** Shafiq Rahman

- **Phone:** 01762262836

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Faridpur

**State:** Hamirdi Community Clinic

**Status:** RECRUITING

**Zip:** 7830

#### Overall Officials

**Official 1:**

**Affiliation:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

**Name:** Razia Sultana, MBBS

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000009369

- Term: Neoplasms

- ID: D000002294

- Term: Carcinoma, Squamous Cell

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000018307

- Term: Neoplasms, Squamous Cell

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M28268

- Name: Keratosis, Actinic

- Relevance: LOW

- As Found: Unknown

- ID: M10668

- Name: Keratosis

- Relevance: HIGH

- As Found: Keratosis

- ID: M5190

- Name: Bowen's Disease

- Relevance: HIGH

- As Found: Bowen's Disease

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20451

- Name: Neoplasms, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: T810

- Name: Bowen's Disease

- Relevance: HIGH

- As Found: Bowen's Disease

### Condition Browse Module - Meshes

- ID: D000001913

- Term: Bowen's Disease

- ID: D000007642

- Term: Keratosis

### Intervention Browse Module - Browse Branches

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

### Intervention Browse Module - Browse Leaves

- ID: M13485

- Name: Petrolatum

- Relevance: LOW

- As Found: Unknown

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
