Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis

Arsenic is one of the largest mass poisonings in Bangladesh. Arsenic keratosis of the palm and sole is a common feature of arsenicosis. Brinjal or eggplant ubiquitous vegetable found in different parts of the world, including Bangladesh, scientifically known as Solanum melongena. A study showed ointment containing crude extract of Solanum melongena peel origin is effective in arsenic keratosis. Solasodine is one of the active compounds of Solanum melongena peel. In the current study, an ointment containing a single compound solasodine isolated from Solanum melongena peel . The ointment made from solasodine extract was distributed among arsenic keratosis patients to see the effect.

Study Overview

• Status: Unknown
• Conditions: Keratotic Nodular Size
• Intervention / Treatment: Drug: Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment

Detailed Description

About millions of Bangladeshi people are chronically exposed to high arsenic concentrations (above 50 micrograms/liter) through contaminated drinking water and thus suffer from arsenic-related health hazards called arsenicosis. Arsenic keratosis is one of the commonest skin manifestations of arsenicosis that occur in the palm and sole that is troublesome for the working people and females suffered a negative socio-economic impact.

Two studies were conducted in the same department where topical ointment prepared from the crude extract of S. melongena peel was found effective in arsenical keratosis.

The present study was conducted to confirm the previous study and identify that solasodine isolated from S. melongena peel is responsible for the cure of the lesions of arsenical keratosis. Thus, it may be possible for the chemical synthesis of solasodine, and an effective, inexpensive topical ointment can be prepared for the cure of arsenical keratosis.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bangladesh
  • Comilla, Bangladesh, 3540
    • Muradnagar Upazilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of moderate to severe palmar arsenical keratosis
• 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
• Patient allergic to brinjal (eggplant)
• Patient taken any treatment of arsenicosis for the last six months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment; An ointment containing solasodine extract of solanum melongena peel origin applied to patients with palmar arsenical keratosis; dose-twice daily for 12 weeks. Keratotic nodular size observation after 12 weeks	Drug: Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment; An ointment containing solasodine extract of solanum melongena peel origin applied to patients with palmar arsenical keratosis; dose-twice daily for 12 weeks.Keratotic nodular size observation after 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arsenical Keratotic nodular size of the palm	Keratotic nodular size or lesion size will be measured by slide calipers	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2018
• Primary Completion (Anticipated): January 15, 2021
• Study Completion (Anticipated): January 15, 2021

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Keratosis
• Other Study ID Numbers: BSMMU/2019/10655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No