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

NCT05362513 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-05

No results posted yet for this study

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.

Conditions

  • Scabies

Interventions

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.

Sponsors & Collaborators

  • Combined Military Hospital Abbottabad

    lead OTHER

Principal Investigators

  • Naheed Khan, MBBS · Cpsp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Pakistan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05362513 on ClinicalTrials.gov