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Completed

NCT Number: NCT05819983

Ivermectin/ Permethrin for Scabies

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.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ciumbuleuit Public Health Centre

Bandung, West Java, 40142, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivermectin Tablets

Drug

Ivermectin 200µg/kg BW

Permethrin Cream

Drug

Permethrin cream 5%

Primary outcomes

  1. The severity of scabetic lesions

    Time frame: 5 weeks

    Determined by counting the number of lesions and graded as:

    0 = Free of lesions (no scabies) 10 or fewer lesions = Mild 11-49 lesions= Moderate 50 or more lesions= Severe

  2. The severity of pruritus

    Time frame: 5 weeks

    Evaluated by the patients graded on a scale 0-10 (using VAS score):

    0= No pruritus 1-3= Mild 4-6= Moderate 7-10= Severe

Secondary outcomes

  1. Clinical improvement

    Time frame: 4 weeks

    Defined as a reduction in both the number of lesions and symptoms and graded as:

    Mild= Less than 50% reduction in the number of lesions and pruritus Moderate= More than or equal to 50% reduction in the number of lesions and pruritus Good= Complete clearance of the lesion and pruritus

  2. Side effects

    Time frame: 4 weeks

    Evaluated the side effects after using oral ivermectin or permethrin 5% cream.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

Comparison of Effectiveness Between Three Dosages of Oral Ivermectin, Two Dosages of Oral Ivermectin, and Two Applications of Topical Permethrin In Scabies Patients

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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