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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary: Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation injection and oral supplementation for osteoarthritis. Hyaluronic acid is extensively utilized in many cosmetic products because of its moisturizing property as a topical moisturizing agent. It is also used as dermal fillers for wrinkle correction. It has anti-inflammatory effect and used in the treatment of different type of ulcers. In case of acute radioepithelitis, 0.2% hyaluronic acid is used to reduce inflammation. Hyaluronic acid has found important application in drug delivery system. Recently 3% diclofenac in 2.5% hyaluronic acid gel has been approved for the treatment of actinic keratoses as a unique topical vehicle for the localized delivery of drug to the skin. It is also used as a vehicle for various anticancer drugs. As it has many effective topical applications, it can be used in arsenical keratosis. In the case of arsenical keratotic nodule, topical application of hyaluronic acid may cause repeated hydration of the skin as a result keratosis tends to soften and disappear. Therefore, the study will be conducted to identify the outcome of cock's comb extract in the treatment of arsenical skin lesion. Biological activity and cytotoxicity of cock's comb extract have been identified after performing brine shrimp bioassay test. Twenty-five patients with severe palmar (>5 mm) arsenical keratosis will be recruited on the basis of inclusion and exclusion criteria. Before the study, water and nail samples will be collected to confirm arsenicosis. Blood samples will be collected for liver and kidney function test to observe any adverse effects of topically applied cock's comb extract both before and after the study. The cream will be prepared with 0.01% cock's comb extract mixed with olive oil, bee wax and benzoic acid for topical application 2 days prior visit of the recruited patients. The patient will be applied the cream on the affected area with a clean fingertip by rub
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Current Primary Outcome: Changes in palmer arsenical keratosis [ Time Frame: [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: No] ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in arsenic level in nail [ Time Frame: [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: Yes] ]

Original Secondary Outcome: Same as current

Information By: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Dates:
Date Received: April 12, 2017
Date Started: November 17, 2016
Date Completion: January 31, 2018
Last Updated: April 20, 2017
Last Verified: April 2017