Effect of Solanum Melongena Extract in the Treatment of Arsenical Skin Lesion
Condition: Arsenical Keratosis
MeSH terms: Keratosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Solanum melongena is a common vegetable contains phytochemicals which prevent, reduce or
      delay the oxidation of DNA and alter the cellular signal transduction pathways controlling
      cell proliferation and apoptosis of human cancer. The skin of Solanum melongena peel contains
      nasunin an anthocyanins and chlorogenic acid which have anti-inflammatory, antioxidant,
      antimutagenic and antiangiogenic properties. Extract of Solanum melongena is used in actinic
      keratosis and Squamous cell carcinoma of the skin. This study will determine any change in
      arsenical skin lesion after administrating Solanum melongena extract cream.
    

Detailed description: 
      Bangladesh is grappling with the world greatest ever environmental health disaster in
      history. About three decades, more than thirty millions people subsistence with this problem
      without any potential treatment. So, now arsenic crisis as a major issue and becomes a demand
      of era to find out the way to solve this problem. Chronic ingestion of arsenic contaminated
      water is a silent killer of the human because even it may cause death by carcinoma. Arsenic
      has an affinity to keratin-rich tissue like skin, hair, nail due to the presence of
      sulphydryl group, as a consequence, they manifest of clinical symptoms like hyperpigmentation
      or melanosis, diffuse dark brown spot of skin or characteristic rain drop appearance over the
      trunks, limbs; keratosis. Even due to prolong exposure to arsenic e.g. invasive skin lesion
      as Bown's disease and squamous cell carcinoma appear. Arsenic as neglected disease arsenic
      patients has no established treatment except preventive and supportive treatment of melanosis
      by drinking arsenic free water and salicylic acid as keratolytic substance. But the malignant
      condition of arsenic skin lesion treatment is not yet documented. Solanum melongena belongs
      to Leptostemonum Clade (the "spine" solanums) species-rice in solanaceae. It also called
      brinjal or eggplant. Solanum melongena is a common vegetable contains phytochemicals which
      prevent, reduce or delay the oxidation of DNA and alter the cellular signal transduction
      pathways controlling cell proliferation and apoptosis of human cancer. Polyphenols of Solanum
      melongena exhibit an anticancer effect both in vitro and in vivo experiments. Polyphenol
      reduces scavenge free radicals, induce apoptosis, inhibit cell proliferation and angiogenesis
      and exhibit phytoestrogen activity. On other hand, they suppress the NF-κB and the activating
      protein (AP-1), inhibit the mitogen-activated proteins (MAPKs), the protein kinase and growth
      factor receptor-mediated pathways which are involved in cell cycle arrest and possess
      anti-inflammatory properties. Solanum melongena has solasodine glycoalkaloids which are
      cytotoxic and bind with endogenous endocytic lectin of cancer cell membrane and induce
      apoptosis and cell death both in vivo and in vitro. The skin of Solanum melongena peel
      contains nasunin an anthocyanins and chlorogenic acid which have anti-inflammatory,
      antioxidant, antimutagenic and antiangiogenic properties. It has a cytotoxic effect on brine
      shrimp. Therefore, this study will be conducted to determine is there any change in the
      patient with arsenical skin lesions before and after application of topical Solanum melongena
      extract cream. Twenty-five patients with arsenical skin lesions will be recruited on the
      basis of inclusion and exclusion criteria after IRB approval. The patients will be applied
      Solanum melongena extract cream twice daily for 12 weeks without any interruption. Water and
      nails samples will be collected for confirming the diagnosis. Blood samples will be collected
      before and after treatment to evaluate the liver and renal function tests. So, this study
      will determine any change in arsenical skin lesion after administrating Solanum melongena
      extract cream.
    

Intervention name(s): Solanum melongena peel extract 0.05%
Intervention type(s): Drug
Intervention description(s): Administered topically twice daily for 12 weeks
Other intervention name(s): Solanum melongena peel extract cream
Intervention model: Single Group Assignment
Intervention model description: Solanum melongena peel extract
Masking: None (Open Label)
Primary purpose: Treatment