Ivermectin/ Permethrin for Scabies

NCT ID: NCT05819983

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2023-03-06

Brief Summary

Scabies is a skin disease characterized by intense itching that worsens at night. It is very contagious, still has a high occurrence rate, and impacts patient quality of life. The use of scabicide followed by a clean and healthy lifestyle is the principle of scabies therapy. The primary treatment option for scabies is permethrin 5% cream. Ivermectin is an alternate treatment for scabies.

Detailed Description

Permethrin acts by disrupting the sodium channel current, resulting in delayed repolarization, paralysis, and death of the parasite. Sodium channels are ubiquitous and therefore permethrin acts at all stages of the life cycle of the parasite. Permethrin 5% cream is applied overnight once a week for two weeks to the entire body. This drug has a number of negative side effects, such as being expensive, uncomfortable, less applicable, and in some cases resistant to permethrin. Ivermectin is an alternate treatment for scabies and should be administered twice, one week apart. Ivermectin acts by binding selectively and with high affinity to glutamate-gated chloride ion channels, which are present in invertebrate nerve and muscle cells, resulting in paralysis and death of the parasite. Two doses of ivermectin one week apart are recommended for scabies treatment. Due to its specific site of action, ivermectin may not be effective against the younger stages of the parasite inside the egg because the nervous system has not yet developed. This drug is safe, more affordable, more practical to use, and has minimal side effects. The disadvantage of ivermectin is it does not kill all the stages of S. scabiei, necessitating multiple doses. According to several earlier research, topical permethrin is just as effective as oral ivermectin at one or two doses.

There hasn't been any research on how well three doses of oral ivermectin treat scabies. As a result of no data, our trial is looking forward to answering the comparison of the effectiveness between three dosages of oral ivermectin, two dosages of oral ivermectin, and two applications of topical permethrin in scabies patients.

Conditions

Scabies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oral ivermectin 3 dosages and placebo

Twenty patients will be administered randomly oral ivermectin 200µg/kg BW on days 1, 2, and 8 and also placebo cream on days 1 and 8

Placebo cream: Cream base

Group Type: ACTIVE_COMPARATOR

Ivermectin Tablets

Intervention Type: DRUG

Ivermectin 200µg/kg BW

Oral ivermectin 2 dosages and placebo

Twenty patients will be administered randomly oral ivermectin 200µg/kg BW on days 1 and 8 and also oral placebo on day 2, placebo cream on days 1 and 8

Placebo cream: Cream base

Group Type: ACTIVE_COMPARATOR

Ivermectin Tablets

Intervention Type: DRUG

Ivermectin 200µg/kg BW

Permethrin 5% cream 2 applications and placebo

Twenty patients will be administered randomly permethrin 5% cream on days 1 and 8 and also oral placebo on days 1, 2, and 8

Placebo: vitamin B complex

Group Type: ACTIVE_COMPARATOR

Permethrin Cream

Intervention Type: DRUG

Permethrin cream 5%

Interventions

Ivermectin Tablets

Ivermectin 200µg/kg BW

Intervention Type: DRUG

Permethrin Cream

Permethrin cream 5%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female
• Age 6 years or above
• Body weight 15kg or above
• Clinical establishment of diagnosed scabies

Exclusion Criteria

• Pregnant or breastfeeding woman
• Scabies with secondary infection
• Scabies with eczematization
• History of receiving scabies treatment in the last four weeks
• History of drug hypersensitivity

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hendra Gunawan,, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Locations

Ciumbuleuit Public Health Centre

Bandung, West Java, Indonesia

Countries

Indonesia

Other Identifiers

DV202303.01

Identifier Type: -

Identifier Source: org_study_id