Clinical trial NCT05819983: Ivermectin/ Permethrin for Scabies
Official title: Comparison of Effectiveness Between Three Dosages of Oral Ivermectin, Two Dosages of Oral Ivermectin, and Two Applications of Topical Permethrin In Scabies Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scabies
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The severity of scabetic lesions
timeFrame: 5 weeks
measure: The severity of pruritus
timeFrame: 5 weeks
Secondary outcomes:
measure: Clinical improvement
timeFrame: 4 weeks
measure: Side effects
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Ciumbuleuit Public Health Centre
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Hendra Gunawan,, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: