Clinical trial NCT02352987: Effect of Neem Extract, Propylene Glycol and Salicylic Acid Combination in the Treatment of Arsenical Palmar Keratosis
Official title: Randomized, Single Blind, Placebo Controlled Clinical Trial to See the Effect of Combination of Neem, Propylene Glycol and Salicylic Acid in the Treatment of Arsenical Palmar Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Arsenic Poisoning
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to find out the effectiveness of combination of ethanol extract of neem leaf, propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar arsenical keratosis.

Detailed description: Arsenic, a non-essential trace element, is a major water pollutant in Bangladesh. Arsenical keratosis, which occurs in the palm and sole, is a common symptom of arsenicosis. The objective of this study is to find the effectiveness of combination of topical administration of the ethanol extract of leaf of neem (Azadirachta indica), propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar arsenical keratosis. On the basis of inclusion and exclusion criteria, 30 patients of moderate palmar arsenical keratosis will be recruited from an arsenic affected area. They will be divided into two groups: study group and placebo comparator group. Each group consisting of 15 members. Study group will be given combination of ethanol extract of leaf of neem, propylene glycol (40%) and salicylic acid (10%) to apply on palm overnight once daily for 12 weeks. On the other hand placebo comparator group will be given salicylic (10%) acid to apply on palm overnight once daily for 12 weeks. Water and nail samples will be collected before starting recruitment to confirm arsenicosis. After conclusive recruitment of the subjects the objective, nature, purpose and potential risks and benefits of all procedures of the study will be explained in details to the patients and informed written consent will be taken from them. Detail history, clinical examination and photograph (palm) will also be collected. Clinical improvement will be assessed by measuring palmar nodular size on both hands, before starting treatment and after 12 weeks completion of treatment and perception of patients about their improvement. The study will explore the effectiveness of topical use of combination of ethanol extract of neem, propylene glycol and salicylic acid for the treatment of palmar arsenical keratosis.

Eligibility criteria: Inclusion Criteria:

* Age: 18-60 years
* Palmar arsenical keratosis
* Drinking arsenic contaminated water (\>50 µg/L) for more than six months
* Patient voluntarily agree to participate

Exclusion Criteria:

* Pregnancy and lactating mother
* Skin lesion :Psoriasis and eczema
* Bowen's disease
* Any kind of systemic disease, inflammatory disease and infectious condition that affect skin (Diabetes mellitus, Rheumatoid arthritis, Systemic lupus erythematosus , Hepatitis and Tuberculosis)
* Hypersensitivity to any drug
* Patient who received treatment within last three months

Primary outcomes:
measure: Changes in palmer arsenical keratosis
timeFrame: 0 weeks (baseline), 12 weeks (end)
Secondary outcomes:
measure: Changes in arsenic level in nail
timeFrame: 0 weeks (baseline), 12 weeks (end)
Other outcomes:
Locations:
city: Comilla
country: Bangladesh
facility: Muradnagar Health Complex
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Mir Misbahuddin
role: STUDY_DIRECTOR
References: