Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
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|ClinicalTrials.gov Identifier: NCT05362513|
Recruitment Status : Completed
First Posted : May 5, 2022
Last Update Posted : May 5, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Scabies||Drug: Ivermectin Tablets Drug: Permethrin Cream||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies|
|Actual Study Start Date :||June 1, 2021|
|Actual Primary Completion Date :||November 30, 2021|
|Actual Study Completion Date :||November 30, 2021|
Active Comparator: Group A(permethrin topical)
Group A received Permethrin 5% twice with a one-week interval, whereas 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.
Active Comparator: Group B oral ivermectin
Group A received Permethrin 5% twice with a one-week interval, whereas Group B received a single dose of oral ivermectin 200 mcg per kg
Drug: Ivermectin Tablets
Group B received a single dose of oral ivermectin 200 mcg per kg
- Complete clearance (outcome assessment at 7 and 14 days post initiation of treatment) [ Time Frame: 2 weeks ]
For randomization, the final recruited 100 participants (57 females and 43 men; mean+SD age 35.28+18.51 years, range 5 to 80), randomly assigned to one of two groups i.e. Group A received Permethrin 5% twice with a one-week interval, whereas Group B received a single dose of oral ivermectin 200 mcg per kg. They were instructed not to take any antipruritic or topical medicine.
The recruited patients were evaluated and assessed clinically at 2-4-week intervals after treatment by the experienced practitioners who were blinded to the treatment received, in accordance with the criteria described while recruiting the patients.
- ADVERSE EFECTS OF DRUGS [ Time Frame: 2 weeks ]Skin itching, swelling, and erythema can happen with scabies patients and may exacerbate following permethrin therapy, Mild stinging or burning might occur as a result of the absorption of dead parasite proteins .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05362513
|Combined military hospital|
|Abbottābād, Kpk, Pakistan|
|Principal Investigator:||Naheed Khan, MBBS||Cpsp|