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

Primary Purpose

Keratotic Nodular Size

Status
Unknown status
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratotic Nodular Size

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muradnagar Upazilla

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Arsenical Keratotic nodular size of the palm
Keratotic nodular size or lesion size will be measured by slide calipers

Secondary Outcome Measures

Full Information

First Posted
December 30, 2020
Last Updated
December 31, 2020
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT04693000
Brief Title
Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis
Official Title
Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 23, 2018 (Actual)
Primary Completion Date
January 15, 2021 (Anticipated)
Study Completion Date
January 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratotic Nodular Size

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment
Intervention Description
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 Measure Information:
Title
Arsenical Keratotic nodular size of the palm
Description
Keratotic nodular size or lesion size will be measured by slide calipers
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Muradnagar Upazilla
City
Comilla
ZIP/Postal Code
3540
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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