Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies (GALECRUSTED)

A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400µg/kg Ivermectin /5% Permethrin / Emollient Cream Regimen in Patients With Crusted Scabies as Compared to a 200µg/kg Ivermectin /5% Permethrin /Emollient Cream Regimen

Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).

Study Overview

• Status: Completed
• Conditions: Ivermectin; Gale; Severe Forms of Scabies; Oral Parasitic Drug
• Intervention / Treatment: Drug: Ivermectin 400 µg/kg; Drug: Ivermectin 200 µg/kg

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Giao DO-PHAM, MD; Phone Number: +33 (0)1 49 81 45 09; Email: pham.do@chicreteil.fr

Study Locations

• France
  • Creteil, France, 94010
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients ≥ 18 years old, diagnosed with severe forms of scabies

1. clinical criteria : cutaneous lesions of scabies

   • crusted scabies: at least two sites of hyperkeratosis will define crusted scabies and/or
   • profuse scabies : spreading lesions with erythematous scaly eruption of the neck, face or trunk without hyperkeratosis

2. paraclinical criteria:

   • Positive parasitological test
   • and/or dermoscopic exam with signs of scabies

Effective contraception for women in age of pregnancy Written consent from patient or his/her legal representant, trustworthy person or family member Affiliated to a social security scheme

Exclusion Criteria:

• Pregnant and/or breastfeeding women
• Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream
• Use of anti parasitic drug (ivermectin or albendazole) within the past 7 days
• Abnormal liver test results: ALT and/or AST >3N within the past 7 days (within 6 months if no hepatic history)
• Participation in other biomedical drug research
• Patient deprived of freedom
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral ivermectin 400 µg/kg; Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)	Drug: Ivermectin 400 µg/kg; Oral ivermectin 400 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other)daily on skin (D0 to D28)
Active Comparator: Oral ivermectin 200 µg/kg; Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)	Drug: Ivermectin 200 µg/kg; Oral ivermectin 200 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other) daily on skin (D0 to D28)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams	Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days	Days 21+/-2 days
Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions		Days 28+/- 2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of adverse effects	Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Giao DO-PHAM, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): January 12, 2022
• Study Completion (Actual): January 12, 2022

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimated): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Ivermectin; Gale; Severe forms of scabies; Oral parasitic drug
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Mite Infestations; Scabies; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: P140939

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