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

NCT05362513 | Completed Phase 1

• 2 other identifiers: CMHatd-ETH-23-derm-22131/CPSP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Permethrin 5%; scabies; ivermectin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ADVERSE EFECTS OF DRUGS

  2 weeks

Study Arms (2)

Group A(permethrin topical)

ACTIVE COMPARATOR

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 B oral ivermectin

ACTIVE COMPARATOR

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

Interventions

Ivermectin Tablets DRUG

Group B received a single dose of oral ivermectin 200 mcg per kg

Group B oral ivermectin

Permethrin Cream DRUG

Group A received Permethrin 5% twice with a one-week interval.

Group A(permethrin topical)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

Combined military hospital

Abbottābād, Kpk, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 24791346 BACKGROUND

MeSH Terms

Conditions

Scabies

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Naheed Khan, MBBS

  Cpsp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 5, 2022
• Study Start: June 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)