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

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.

Study Overview

• Status: Completed
• Conditions: Scabies
• Intervention / Treatment: Drug: Permethrin Cream; Drug: Ivermectin Tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Kpk
    • Abbottābād, Kpk, Pakistan
      • Combined Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• More than 2 years
• More than 15kg of body weight
• attended the Dermatology department

Exclusion Criteria:

• Patients under the age of two years
• pregnant
• breastfeeding women
• those with a background of seizures, severe symptoms of systemic illnesses,
• immunosuppression diseases,
• Norwegian scabies
• those who had taken any topical or systemic acaricide medication for one month before the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete clearance (outcome assessment at 7 and 14 days post initiation of treatment)	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADVERSE EFECTS OF DRUGS	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 .	2 weeks

Collaborators and Investigators

• Sponsor: Combined Military Hospital Abbottabad
• Investigators: Principal Investigator: Naheed Khan, MBBS, CPSP

Publications and helpful links

General Publications

• Ranjkesh MR, Naghili B, Goldust M, Rezaee E. The efficacy of permethrin 5% vs. oral ivermectin for the treatment of scabies. Ann Parasitol. 2013;59(4):189-94.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ivermectin; Permethrin 5%; scabies
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Mite Infestations; Scabies; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antiparasitic Agents; Permethrin; Ivermectin
• Other Study ID Numbers: CMHatd-ETH-23-derm-22; 131/CPSP (OTHER: CPSP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No