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

NCT04693000 | Unknown Phase 2

• 1 other identifier: BSMMU/2019/10655
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratotic Nodular Size

Outcome Measures

Primary Outcomes (1)

• Arsenical Keratotic nodular size of the palm

  Keratotic nodular size or lesion size will be measured by slide calipers

  12 weeks

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment DRUG

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

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

Eligibility Criteria

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

You may qualify if:

• Presence of moderate to severe palmar arsenical keratosis
• Drinking arsenic-contaminated water for at least six months
• Patient voluntarily agreed to participate

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Muradnagar Upazilla

Comilla, 3540, Bangladesh

Location

MeSH Terms

Interventions

Therapeutics

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: MBBS, MD(Phase B) Resident

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: September 23, 2018
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)