Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Anti-Infective Agents

Dermatologic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Herbal and Botanical

Salicylic Acid

Petrolatum

Salicylates

Clotrimazole

Miconazole

Antifungal Agents

Keratolytic Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Emollients

Neem

Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.

Leaf extract of A. indica

Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.

Salicylic Acid (6%)

Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.

Petroleum jelly

Mir Misbahuddin, MBBS, PhD

Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial

The objective of this study is to evaluate the effectiveness of topical administration of the Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated water for more than six months. They will be divided into two groups each will consist of twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid ointment . Water and nail sample will be collected before starting recruitment to confirm diagnosis. Then again nail sample will be collected before and after the study to see the level of arsenic in skin. Effects will be observed after every two weeks and change will be detected as nil, mild reduction, moderate reduction and fully cured.

Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial

Size and number of keratotic lesions will be reduced. These will be expressed in score.

Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Prof. and Chairman

Micronutrients

Vitamins

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Trace Elements

Antioxidants

Protective Agents

Nigella

Tocopherol

Tocotrienol

Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks

Vitamin E (200 mg, soft capsule) plus Placebo (refined oil in soft capsule with same size and color as that contains N sativa) twice daily, orally for 12 weeks

Nigella sativa

Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)

Placebo

Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis

Depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis patients (both male and female; age range 18- 60 years) will be recruited from an arsenic affected area. Study population will be divided randomly into two equal groups: one group will receive vitamin E capsules (200 mg) plus placebo and another group will receive vitamin E capsule plus N. sativa capsules (500 mg) twice daily for 12 weeks. Drinking water (50 mL) and urine (50 mL) samples will be collected before starting the study and estimate the amount of total arsenic in order to confirm the diagnosis. Nail (approx. 1 g) and blood (5 mL) samples will be collected both before and completion of the study to see the efficacy and safety of the drug. Clinical examinations will be done at regular interval (two weeks). Clinical features and adverse effects will be recorded using a structured data collection sheet. Plasma cholesterol, vitamin E, and total antioxidant, serum transaminase, billirubin, creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of N. sativa on palmer arsenical keratosis patients

Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

Signs and symptoms of palmer arsenical keratosis will be examined by one trained doctor at the temporary arsenic camp at regular interval (2 weeks). Another doctor will note the findings of the patient in the data collection sheet without informing the previous data to the former doctor.

Signs and symptoms of moderate arsenical keratosis will be assessed by estimating the number and size of keratotic lesions and expressed into scoring.

Amount of arsenic in nails will be estimated by Atomic Fluorescence spectrometry (AFS) both before and after completion of treatment.

To see any change in the concentration of plasma vitamin E levels after use of N.sativa capsules. This parameter will be estimated by spectrophotometric method.

To see any change in the concentration of serum cholesterol levels after use of N. sativa. This parameter will be estimated by spectrophotometric method.

To see any change in the concentration of serum bilirubin, transaminase levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.

To see any change in the concentration of blood urea and serum creatinine levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.

Prof. and Chairman, Department of Pharmacology

Substance Related Disorders

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Melanosis

Poisoning

Arsenic Poisoning

Chemically-Induced Disorders

Hyperpigmentation

Pigmentation Disorders

Heavy Metal Poisoning

Syndrome

Neurotoxicity Syndromes

Selenium

Sodium Selenite

Selenious Acid

Patients who receive treatment (selenium)

200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.

sodium selenite

dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast

placebo

Julian E Spallholz, PhD

Paul F La Porte, PhD

Selim Ahmed, MBBS, FCPS

Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of \[(GS)2AsSe\]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients.

Objective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.

Selenium in the Treatment of Arsenic Toxicity and Cancers

Selenite in the Detoxification of Arsenic and the Prevention of Arsenical Melanosis and Cancers Amongst Bangladeshi Arsenicosis Patients: A 48-week, Randomized, Double-blinded, Placebo-controlled Phase III Trial

Arsenical melanosis was recorded in 4 quadrants of each patients' torsos using the Dermlite epiluminescence microscopy system. The images were then scored in a blinded, randomized fashion by a dermatologist.

The levels of arsenic in patients' blood was measured to determine whether intervention had a differential effect.

The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect.

National Cancer Institute (NCI)

American Cancer Society, Inc.

Texas Tech University

Professor of Nutrition & Biochemistry, Division of Nutritional Sciences, College of Human Sciences, Texas Tech University.

Chronic Graft Versus Host Disease

Other Dietary Supplements

Zinc

Spirulina

Linoleate

Patients of arsenical keratosis may be treated with spirulina. Is this improvement related to the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? To understand this, patients of palmer arsenical keratosis (n=10), arsenic exposed controls (n=10) and healthy volunteers (n=10) will be treated with spirulina powder 10 g/day orally for 12 weeks. Skin extracts will be collected both before and after supplementation from the palm and dorsum for estimation of zinc, vitamin E and linoleic acid levels.

Patients of arsenical keratosis remain untreated due to unavailability of effective drug. To find out an effective drug, the pathogenesis of keratosis should be understood. Spirulina is one of the dietary supplements, that improves the symptoms of keratosis. Is this improvement related to the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? Ten patients of moderate palmer arsenical keratosis will be treated with spirulina powder 10 g/day orally for 12 weeks. Skin extracts will be collected both before and after supplementation from the palm and dorsum using a mixture of chloroform and ethanol. Zinc, vitamin E and linoleic acid levels will be estimated from the extracts. Similar protocol of spirulina administration and the collection of skin extracts will be done in arsenic exposed controls (n=10) and healthy volunteers (n=10).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis	NCT01731756	Arsenical Kerat...	Leaf extract of... Salicylic Acid ... Petroleum jelly	18 Years - 60 Years	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis	NCT01735097	Arsenical Kerat...	Vitamin E Nigella sativa Placebo	18 Years - 60 Years	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Selenium in the Treatment of Arsenic Toxicity and Cancers	NCT01442727	Arsenical Melan... Arsenical Kerat... Arsenical Cance... Arsenicosis Arsenic Exposur... Arsenic Toxicit... Arsenic Poisoni...	sodium selenite placebo	12 Years - 55 Years	Texas Tech University
Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis	NCT01735097	Arsenical Kerat...	Vitamin E Nigella sativa Placebo	18 Years - 60 Years	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid Levels in Palm Skin Following Chronic Exposure to Arsenic	NCT01752972	Arsenical Kerat...	Spirulina	20 Years - 40 Years	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Spots Global Cancer Trial Database for arsenical keratosis