Ivermectin/ Permethrin for Scabies

Study Overview
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Brief Summary
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Scabies is a skin disease characterized by intense itching that worsens at night. It is very contagious, still has a high occurrence rate, and impacts patient quality of life. The use of scabicide followed by a clean and healthy lifestyle is the principle of scabies therapy. The primary treatment option for scabies is permethrin 5% cream. Ivermectin is an alternate treatment for scabies.

Detailed Description
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Permethrin acts by disrupting the sodium channel current, resulting in delayed repolarization, paralysis, and death of the parasite. Sodium channels are ubiquitous and therefore permethrin acts at all stages of the life cycle of the parasite. Permethrin 5% cream is applied overnight once a week for two weeks to the entire body. This drug has a number of negative side effects, such as being expensive, uncomfortable, less applicable, and in some cases resistant to permethrin. Ivermectin is an alternate treatment for scabies and should be administered twice, one week apart. Ivermectin acts by binding selectively and with high affinity to glutamate-gated chloride ion channels, which are present in invertebrate nerve and muscle cells, resulting in paralysis and death of the parasite. Two doses of ivermectin one week apart are recommended for scabies treatment. Due to its specific site of action, ivermectin may not be effective against the younger stages of the parasite inside the egg because the nervous system has not yet developed. This drug is safe, more affordable, more practical to use, and has minimal side effects. The disadvantage of ivermectin is it does not kill all the stages of S. scabiei, necessitating multiple doses. According to several earlier research, topical permethrin is just as effective as oral ivermectin at one or two doses. There hasn't been any research on how well three doses of oral ivermectin treat scabies. As a result of no data, our trial is looking forward to answering the comparison of the effectiveness between three dosages of oral ivermectin, two dosages of oral ivermectin, and two applications of topical permethrin in scabies patients.

Official Title
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Comparison of Effectiveness Between Three Dosages of Oral Ivermectin, Two Dosages of Oral Ivermectin, and Two Applications of Topical Permethrin In Scabies Patients

Conditions
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Scabies

Intervention / Treatment
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* Drug: Ivermectin Tablets
* Drug: Permethrin Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age 6 years or above Body weight 15kg or above Clinical establishment of diagnosed scabies Exclusion Criteria: Pregnant or breastfeeding woman Scabies with secondary infection Scabies with eczematization History of receiving scabies treatment in the last four weeks History of drug hypersensitivity

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral ivermectin 3 dosages and placebo<br>Twenty patients will be administered randomly oral ivermectin 200µg/kg BW on days 1, 2, and 8 and also placebo cream on days 1 and 8 Placebo cream: Cream base | Drug: Ivermectin Tablets<br>* Ivermectin 200µg/kg BW<br>|
| Active Comparator: Oral ivermectin 2 dosages and placebo<br>Twenty patients will be administered randomly oral ivermectin 200µg/kg BW on days 1 and 8 and also oral placebo on day 2, placebo cream on days 1 and 8 Placebo cream: Cream base | Drug: Ivermectin Tablets<br>* Ivermectin 200µg/kg BW<br>|
| Active Comparator: Permethrin 5% cream 2 applications and placebo<br>Twenty patients will be administered randomly permethrin 5% cream on days 1 and 8 and also oral placebo on days 1, 2, and 8 Placebo: vitamin B complex | Drug: Permethrin Cream<br>* Permethrin cream 5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of scabetic lesions | Determined by counting the number of lesions and graded as: 0 = Free of lesions (no scabies) 10 or fewer lesions = Mild 11-49 lesions= Moderate 50 or more lesions= Severe | 5 weeks | 
| The severity of pruritus | Evaluated by the patients graded on a scale 0-10 (using VAS score): 0= No pruritus 1-3= Mild 4-6= Moderate 7-10= Severe | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Defined as a reduction in both the number of lesions and symptoms and graded as: Mild= Less than 50% reduction in the number of lesions and pruritus Moderate= More than or equal to 50% reduction in the number of lesions and pruritus Good= Complete clearance of the lesion and pruritus | 4 weeks | 
| Side effects | Evaluated the side effects after using oral ivermectin or permethrin 5% cream. | 4 weeks |