Ciumbuleuit Public Health Centre
Bandung, West Java, 40142, Indonesia
NCT Number: NCT05819983
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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Notify Me6 year and older
All sexes
Interventional
Phase 4
Bandung, West Java, 40142, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ivermectin 200µg/kg BW
Permethrin cream 5%
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
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
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
Time frame: 4 weeks
Evaluated the side effects after using oral ivermectin or permethrin 5% cream.
Universitas Padjadjaran
Other
Comparison of Effectiveness Between Three Dosages of Oral Ivermectin, Two Dosages of Oral Ivermectin, and Two Applications of Topical Permethrin In Scabies Patients
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