Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion

NCT03127657 | Completed Phase 2

• 1 other identifier: BSMMU-011-CT
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation injection and oral supplementation for osteoarthritis. Hyaluronic acid acts as humectants and topical moisturizing agent to the skin due to excellent moisturizing property. It has anti-inflammatory effect and used in the treatment of ulcer healing and to reduce the intensity of radioepithelitis. It is also used as a topical vehicle for the delivery of drug to the skin in actinic keratosis. In the case of arsenical keratotic nodule, topical application of hyaluronic acid may tends to decrease keratosis by repeated hydration of the skin. Therefore, the study will be conducted to determine any beneficial effect of topical application of cock's comb extract in the treatment of the patients with severe palmar arsenical keratosis.

Conditions

Chronic Arsenic Poisoning

Outcome Measures

Primary Outcomes (1)

• Changes in palmer arsenical keratosis

  Size of keratotic lesion will be decreased

  [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: No]

Secondary Outcomes (1)

• Changes in arsenic level in nail

  [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: Yes]

Study Arms (1)

Cock's comb extract 0.01%

EXPERIMENTAL

25 Patients Cock's comb extract 0.01% Applied topically twice daily for 12 weeks

Drug: Cock's comb extract 0.01%

Interventions

Cock's comb extract 0.01% DRUG

Applied topically twice daily for 12 weeks

Also known as: Cock's comb extract cream

Cock's comb extract 0.01%

Eligibility Criteria

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

You may qualify if:

• Age: 18-60 years
• Sex: Both male and female
• Arsenical keratosis: Presence of severe keratosis (\>5mm) in both palms
• Drinking arsenic contaminated water (\>50 µg/L) for at least more than 6 months
• Patient voluntarily agreed to participate
• Patient who understood the instruction of applying drug and could apply drug as per as instruction

You may not qualify if:

• Age \<18 and \>60 years
• Pregnant and nursing mother
• Palmar psoriasis
• Eczema
• Any kind of systemic disease, inflammatory disease and infectious condition that affect skin for example diabetes mellitus, rheumatoid arthritis, systemic lupus erythrematosus, hepatitis
• Hypersensitivity to avain protein
• Malignancy
• Impaired renal function - if creatinine level \>1.3 mg/dl incase of men and \>1.1 mg/dl in case of women
• Patient who received any treatment of arsenicosis within last three months

Sponsors & Collaborators

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

Study Sites (1)

Shahrashti

Chāndpur, 3600, Bangladesh

Location

Study Officials

• Fatema Chowdhury, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

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: Principal investigator

Model Details: Topical application of cock's comb extract in the treatment of palmar arsenical keratosis

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 25, 2017
• Study Start: January 17, 2016
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: July 13, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)