Effect of Solanum Melongena Extract in the Treatment of Arsenical Skin Lesion

NCT03127670 | Completed Phase 2

• 1 other identifier: BSMMU-012-CT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Arsenical Keratosis

Outcome Measures

Primary Outcomes (1)

• Changes in palmer arsenical keratosis

  Size of keratotic lesion will be decreased

  Clinical outcome [Time Frame:[0 week (baseline),12 weeks (end)] [Safety Issue: No]] [Safety Issue: No]]

Secondary Outcomes (1)

• Changes in the liver function test

  Change in lesion size [ Time Frame: [0 week (baseline), 12 weeks (end)] [Safety Issue: No]] [Safety Issue: No]]

Study Arms (1)

Solanum melongena peel extract 0.05%

EXPERIMENTAL

25 Patients Solanum melongena peel extract 0.05% Twice daily applied topically for 12 weeks

Drug: Solanum melongena peel extract 0.05%

Interventions

Solanum melongena peel extract 0.05% DRUG

Administered topically twice daily for 12 weeks

Also known as: Solanum melongena peel extract cream

Solanum melongena peel extract 0.05%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bhanga

Farīdpur, 7830, Bangladesh

Location

Study Officials

• Mir Misbahuddin, PhD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  STUDY DIRECTOR

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: Professor

Model Details: Solanum melongena peel extract

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 25, 2017
• Study Start: November 14, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 13, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)