Effect of Solanum Melongena Extract in the Treatment of Arsenical Skin Lesion
Primary Purpose
Arsenical Keratosis
Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Solanum melongena peel extract 0.05%
Sponsored by
About this trial
This is an interventional treatment trial for Arsenical Keratosis
Eligibility Criteria
Inclusion Criteria:
- Age: 18-60 years
- Sex: Both male and female
- Arsenicosis: Severe arsenical skin lesions with Bowen's disease or Squamous cell carcinoma
- Drinking arsenic contaminated water (> 50 µg/L) for more than 6 months
- Patient voluntarily agreed to participate
- Patient who understood the instruction of applying medicine and apply it as he or she will be instructed
Exclusion Criteria:
- Age: Less than 18 and above 60 years
- Expectant, Pregnant and lactating mother
- Major health problems Tuberculosis, Hepatic diseases, Renal diseases, Systamic lupus erythrometosis,
- Rheumatoid arthritis
- Patient with other skin diseases like ectopic dermatitis, psoriasis, eczema, drug allergy
- Food allergy of Solanum melongena
- Patient who received treatment within last three months
- Patient with Bowen disease and Squamous cell carcinoma due to other cause
- Patient did not voluntarily agree to participants
Sites / Locations
- Bhanga
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Solanum melongena peel extract 0.05%
Arm Description
25 Patients Solanum melongena peel extract 0.05% Twice daily applied topically for 12 weeks
Outcomes
Primary Outcome Measures
Changes in palmer arsenical keratosis
Size of keratotic lesion will be decreased
Secondary Outcome Measures
Changes in the liver function test
Abnormal liver function tests will be returned toward normal
Full Information
NCT ID
NCT03127670
First Posted
April 12, 2017
Last Updated
July 12, 2018
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT03127670
Brief Title
Effect of Solanum Melongena Extract in the Treatment of Arsenical Skin Lesion
Official Title
Effect of Solanum Melongena Extract in the Treatment of Arsenical Skin Lesion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
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
Solanum melongena is a common vegetable contains phytochemicals which prevent, reduce or delay the oxidation of DNA and alter the cellular signal transduction pathways controlling cell proliferation and apoptosis of human cancer. The skin of Solanum melongena peel contains nasunin an anthocyanins and chlorogenic acid which have anti-inflammatory, antioxidant, antimutagenic and antiangiogenic properties. Extract of Solanum melongena is used in actinic keratosis and Squamous cell carcinoma of the skin. This study will determine any change in arsenical skin lesion after administrating Solanum melongena extract cream.
Detailed Description
Bangladesh is grappling with the world greatest ever environmental health disaster in history. About three decades, more than thirty millions people subsistence with this problem without any potential treatment. So, now arsenic crisis as a major issue and becomes a demand of era to find out the way to solve this problem. Chronic ingestion of arsenic contaminated water is a silent killer of the human because even it may cause death by carcinoma. Arsenic has an affinity to keratin-rich tissue like skin, hair, nail due to the presence of sulphydryl group, as a consequence, they manifest of clinical symptoms like hyperpigmentation or melanosis, diffuse dark brown spot of skin or characteristic rain drop appearance over the trunks, limbs; keratosis. Even due to prolong exposure to arsenic e.g. invasive skin lesion as Bown's disease and squamous cell carcinoma appear. Arsenic as neglected disease arsenic patients has no established treatment except preventive and supportive treatment of melanosis by drinking arsenic free water and salicylic acid as keratolytic substance. But the malignant condition of arsenic skin lesion treatment is not yet documented. Solanum melongena belongs to Leptostemonum Clade (the "spine" solanums) species-rice in solanaceae. It also called brinjal or eggplant. Solanum melongena is a common vegetable contains phytochemicals which prevent, reduce or delay the oxidation of DNA and alter the cellular signal transduction pathways controlling cell proliferation and apoptosis of human cancer. Polyphenols of Solanum melongena exhibit an anticancer effect both in vitro and in vivo experiments. Polyphenol reduces scavenge free radicals, induce apoptosis, inhibit cell proliferation and angiogenesis and exhibit phytoestrogen activity. On other hand, they suppress the NF-κB and the activating protein (AP-1), inhibit the mitogen-activated proteins (MAPKs), the protein kinase and growth factor receptor-mediated pathways which are involved in cell cycle arrest and possess anti-inflammatory properties. Solanum melongena has solasodine glycoalkaloids which are cytotoxic and bind with endogenous endocytic lectin of cancer cell membrane and induce apoptosis and cell death both in vivo and in vitro. The skin of Solanum melongena peel contains nasunin an anthocyanins and chlorogenic acid which have anti-inflammatory, antioxidant, antimutagenic and antiangiogenic properties. It has a cytotoxic effect on brine shrimp. Therefore, this study will be conducted to determine is there any change in the patient with arsenical skin lesions before and after application of topical Solanum melongena extract cream. Twenty-five patients with arsenical skin lesions will be recruited on the basis of inclusion and exclusion criteria after IRB approval. The patients will be applied Solanum melongena extract cream twice daily for 12 weeks without any interruption. Water and nails samples will be collected for confirming the diagnosis. Blood samples will be collected before and after treatment to evaluate the liver and renal function tests. So, this study will determine any change in arsenical skin lesion after administrating Solanum melongena extract cream.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arsenical Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Solanum melongena peel extract
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Solanum melongena peel extract 0.05%
Arm Type
Experimental
Arm Description
25 Patients Solanum melongena peel extract 0.05% Twice daily applied topically for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Solanum melongena peel extract 0.05%
Other Intervention Name(s)
Solanum melongena peel extract cream
Intervention Description
Administered topically twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Changes in palmer arsenical keratosis
Description
Size of keratotic lesion will be decreased
Time Frame
Clinical outcome [Time Frame:[0 week (baseline),12 weeks (end)] [Safety Issue: No]] [Safety Issue: No]]
Secondary Outcome Measure Information:
Title
Changes in the liver function test
Description
Abnormal liver function tests will be returned toward normal
Time Frame
Change in lesion size [ Time Frame: [0 week (baseline), 12 weeks (end)] [Safety Issue: No]] [Safety Issue: No]]
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:
Age: 18-60 years
Sex: Both male and female
Arsenicosis: Severe arsenical skin lesions with Bowen's disease or Squamous cell carcinoma
Drinking arsenic contaminated water (> 50 µg/L) for more than 6 months
Patient voluntarily agreed to participate
Patient who understood the instruction of applying medicine and apply it as he or she will be instructed
Exclusion Criteria:
Age: Less than 18 and above 60 years
Expectant, Pregnant and lactating mother
Major health problems Tuberculosis, Hepatic diseases, Renal diseases, Systamic lupus erythrometosis,
Rheumatoid arthritis
Patient with other skin diseases like ectopic dermatitis, psoriasis, eczema, drug allergy
Food allergy of Solanum melongena
Patient who received treatment within last three months
Patient with Bowen disease and Squamous cell carcinoma due to other cause
Patient did not voluntarily agree to participants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir Misbahuddin, PhD
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Study Director
Facility Information:
Facility Name
Bhanga
City
Faridpur
ZIP/Postal Code
7830
Country
Bangladesh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Solanum Melongena Extract in the Treatment of Arsenical Skin Lesion
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