Gale, Ivermectin, Oral Parasitic Drug, Severe Forms of Scabies
Conditions
Keywords
Gale, Severe forms of scabies, Oral parasitic drug, Ivermectin
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).
Interventions
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)
DRUGIvermectin 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)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Rate of adverse effects | Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days |
Countries
France
Outcome results
None listed