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

Phase 3

Completed

• Conditions: Gale; Ivermectin; Severe Forms of Scabies; Oral Parasitic Drug
• Interventions: Drug: Ivermectin 400 µg/kg; Drug: Ivermectin 200 µg/kg

• Registration Number: NCT02841215
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-22
• Study Start: 2017-10-11
• Primary Completion: 2022-01-12
• Study Completion: 2022-01-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral ivermectin 400 µg/kg	Ivermectin 400 µg/kg	Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)
Oral ivermectin 200 µg/kg	Ivermectin 200 µg/kg	Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)

Primary Outcome Measures

Name	Time	Method
Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams	Days 21+/-2 days	Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at 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

Name	Time	Method
Rate of adverse effects	Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France