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

Phase 2

• Conditions: Keratotic Nodular Size
• Interventions: Drug: Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment

• Registration Number: NCT04693000
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

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.

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 Timeline

• Study Start: 2018-09-23
• Status Verified: 2020-12
• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2020-12-30
• Last Update Submitted: 2020-12-31
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment	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

Primary Outcome Measures

Name	Time	Method
Arsenical Keratotic nodular size of the palm	12 weeks	Keratotic nodular size or lesion size will be measured by slide calipers

Trial Locations

Locations (1)

Muradnagar Upazilla; 🇧🇩 Comilla, Bangladesh