Ivermectin/ Permethrin for Scabies

Scabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05819983
• Other study ID #: DV202303.01
• Status: Completed
• Phase: Phase 4
• Start date: January 25, 2023
• Est. completion date: March 6, 2023

Study information

• Verified date: April 2023
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 6, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scabies

Intervention

Drug:
• Ivermectin Tablets
Ivermectin 200µg/kg BW
• Permethrin Cream
Permethrin cream 5%

Locations

Country	Name	City	State
Indonesia	Ciumbuleuit Public Health Centre	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity of scabetic lesions	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	5 weeks
Primary	The severity of pruritus	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	5 weeks
Secondary	Clinical improvement	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	4 weeks
Secondary	Side effects	Evaluated the side effects after using oral ivermectin or permethrin 5% cream.	4 weeks