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

Keratotic Nodular Size Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04693000
• Other study ID #: BSMMU/2019/10655
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 23, 2018
• Est. completion date: January 15, 2021

Study information

• Verified date: December 2020
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratosis
• Keratotic Nodular Size

Intervention

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

Locations

Country	Name	City	State
Bangladesh	Muradnagar Upazilla	Comilla

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arsenical Keratotic nodular size of the palm	Keratotic nodular size or lesion size will be measured by slide calipers	12 weeks