Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion
Condition: Chronic Arsenic Poisoning
MeSH terms: Arsenic Poisoning; Poisoning
Study type: Interventional
Phase: Phase 2

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 description: 
      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 rubbing gently at twice daily for 12 weeks without any
      interruption. Primary parameters will be the measurement of keratotic nodular size by slide
      calipers and perception scoring of the patients by Likert scale before and 12 weeks after the
      study. Secondary parameters will be the measurement of arsenic level in drinking water and
      nails of the recruited patients.
    

Intervention name(s): Cock's comb extract 0.01%
Intervention type(s): Drug
Intervention description(s): Applied topically twice daily for 12 weeks
Other intervention name(s): Cock's comb extract cream
Intervention model: Single Group Assignment
Intervention model description: Topical application of cock's comb extract in the treatment of palmar arsenical keratosis
Masking: None (Open Label)
Primary purpose: Treatment