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Ivermectin/ Permethrin for Scabies

Primary Purpose

Scabies

Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Ivermectin Tablets
Permethrin Cream
Sponsored by
Universitas Padjadjaran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scabies

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ciumbuleuit Public Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Oral ivermectin 3 dosages and placebo

Oral ivermectin 2 dosages and placebo

Permethrin 5% cream 2 applications and placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2023
Last Updated
April 6, 2023
Sponsor
Universitas Padjadjaran
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1. Study Identification

Unique Protocol Identification Number
NCT05819983
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
March 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitas Padjadjaran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scabies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral ivermectin 3 dosages and placebo
Arm Type
Active Comparator
Arm Description
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
Arm Title
Oral ivermectin 2 dosages and placebo
Arm Type
Active Comparator
Arm Description
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
Arm Title
Permethrin 5% cream 2 applications and placebo
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ivermectin Tablets
Intervention Description
Ivermectin 200µg/kg BW
Intervention Type
Drug
Intervention Name(s)
Permethrin Cream
Intervention Description
Permethrin cream 5%
Primary Outcome Measure Information:
Title
The severity of scabetic lesions
Description
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
Title
The severity of pruritus
Description
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
5 weeks
Secondary Outcome Measure Information:
Title
Clinical improvement
Description
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
Title
Side effects
Description
Evaluated the side effects after using oral ivermectin or permethrin 5% cream.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendra Gunawan,, M.D., PhD
Organizational Affiliation
Faculty of Medicine Universitas Padjadjaran Bandung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ciumbuleuit Public Health Centre
City
Bandung
State/Province
West Java
ZIP/Postal Code
40142
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ivermectin/ Permethrin for Scabies

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