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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Severe Forms of Scabies; Gale; Ivermectin; Oral Parasitic Drug

Treatments: Drug: Ivermectin 200 µg/kg; Drug: Ivermectin 400 µg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT02841215

P140939

Details and patient eligibility

About

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).

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 2 patient groups

Oral ivermectin 400 µg/kg

Experimental group

Description:

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

Treatment:

Drug: Ivermectin 400 µg/kg

Oral ivermectin 200 µg/kg

Active Comparator group

Description:

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

Treatment:

Drug: Ivermectin 200 µg/kg