NCT05362513

Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Combined Military Hospital Abbottabad · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

Globally, Scabies infects 300m people each year. In children of developing countries, its prevalence is expected to be about 5 to 10%.In Pakistan, Scabies accounts for 38% of dermatological diseases. Males were more prone to infestation than females, and early school-aged children were the most vulnerable. It was more widespread in urban than in rural areas. A distinct seasonal pattern emerged, with the biggest infestation occurring in the winter and the lowest in the summer. Scabies risk factors estimated 89% of the variation in its prevalence. The classic scabies symptoms include an erythematous papular eruption, burrows, and intense itching. It is usually transmitted by prolonged skin-skin contact. Predilection sites are fingers, axilla, elbows, waist, belly, groin, genital area, etc. Classic scabies can be diagnosed by proper taking history and clinical symptoms. Some of the clinical variations of scabies are Crusted, nodular, and bullous. On examination under a microscope of scrapings collected from skin lesions, finding the mites, eggs, confirms the infestation of scabies . Topical permethrin and oral ivermectin are the medications of choice for scabies mite elimination. Topical Permethrin 5% applied for 9-14 hours for adults than for children only 8-9 hours. Permethrin 5% only single dose is enough but the second dose can be applied after an interval of 2 weeks if the etiology is still there. Ivermectin is now used to treat scabies, with an effective dosage of 150 to 200 μg/kg given once or may give twice after interval of two weeks. The positives include a single dosage and improved compliance in resistant infestations and situations where head-to-toe topical administration is logistically problematic, such as huge outbreaks or mentally impaired individuals. Fever, arthralgia, myalgia, dizziness, headache, hypotension, tachycardia, and lymphadenopathy have all been reported as adverse effects. There have also been reports of a prolonged prothrombin time, a transient EKG, and variations in liver enzymes. The study's implications are to analyze the safety and efficacy of these two drugs in order to better treat patients with evidence-based management and rule out any potential adverse effects.

Detailed description

A randomized controlled trial study (single-blind) was done In the Dermatology Unit of the CMH, Abbottabad from June to November 2021 after Ethical Review Board approval, the 100 patients aged 5-80 years after informed consent were enrolled using a technique of non-probability consecutive sampling. The sample size for two proportions was determined using the WHO sample size calculator, with a threshold of significance of 5%. The anticipated population proportion P1 was 80%, while the anticipated population proportion P2 was 46.6% 12. The sample size was calculated to be 100.

Conditions

• Scabies

Interventions

Type	Name	Description
DRUG	Ivermectin Tablets	Group B received a single dose of oral ivermectin 200 mcg per kg
DRUG	Permethrin Cream	Group A received Permethrin 5% twice with a one-week interval.

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2022-05-05
• Last updated: 2022-05-05

Locations

1 site across 1 country: Pakistan