Ivermectin/ Permethrin for Scabies

NCT05819983 | Completed Phase 4 DMC

• 1 other identifier: DV202303.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Scabies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Clinical improvement

  4 weeks

• Side effects

  4 weeks

Study Arms (3)

Oral ivermectin 3 dosages and placebo

ACTIVE COMPARATOR

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

Oral ivermectin 2 dosages and placebo

ACTIVE COMPARATOR

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

Permethrin 5% cream 2 applications and placebo

ACTIVE COMPARATOR

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

Interventions

Ivermectin Tablets DRUG

Ivermectin 200µg/kg BW

Oral ivermectin 2 dosages and placebo; Oral ivermectin 3 dosages and placebo

Permethrin Cream DRUG

Permethrin cream 5%

Permethrin 5% cream 2 applications and placebo

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age 6 years or above
• Body weight 15kg or above
• Clinical establishment of diagnosed scabies

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Ciumbuleuit Public Health Centre

Bandung, West Java, 40142, Indonesia

Location

MeSH Terms

Conditions

Scabies

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Hendra Gunawan,, M.D., PhD

  Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: January 25, 2023
• Primary Completion: February 1, 2023
• Study Completion: March 6, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

ID (1)