Clinical trial NCT02841215: Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gale
Severe Forms of Scabies
Oral Parasitic Drug
Ivermectin
Keywords: Gale
Severe forms of scabies
Oral parasitic drug
Ivermectin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams
timeFrame: Days 21+/-2 days
measure: Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions
timeFrame: Days 28+/- 2 days
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Giao DO-PHAM, MD
role: PRINCIPAL_INVESTIGATOR
References: