Ivermectin/ Permethrin for Scabies

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

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.

Study Overview

• Status: Completed
• Conditions: Scabies
• Intervention / Treatment: Drug: Ivermectin Tablets; Drug: Permethrin Cream

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Bandung, West Java, Indonesia, 40142
      • Ciumbuleuit Public Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Ivermectin Tablets; Ivermectin 200µg/kg BW
Active Comparator: 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	Drug: Ivermectin Tablets; Ivermectin 200µg/kg BW
Active Comparator: 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	Drug: Permethrin Cream; Permethrin cream 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Side effects	Evaluated the side effects after using oral ivermectin or permethrin 5% cream.	4 weeks

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Principal Investigator: Hendra Gunawan,, M.D., PhD, Faculty of Medicine Universitas Padjadjaran Bandung

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Mite Infestations; Scabies; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antiparasitic Agents; Permethrin; Ivermectin
• Other Study ID Numbers: DV202303.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No