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

NCT02841215 | Completed Phase 3 DMC

• 1 other identifier: P140939
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Gale; Severe forms of scabies; Oral parasitic drug; Ivermectin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Rate of adverse effects

  Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days

Study Arms (2)

Oral ivermectin 400 µg/kg

EXPERIMENTAL

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

Drug: Ivermectin 400 µg/kg

Oral ivermectin 200 µg/kg

ACTIVE COMPARATOR

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

Drug: Ivermectin 200 µg/kg

Interventions

Ivermectin 200 µg/kg DRUG

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)

Oral ivermectin 200 µg/kg

Ivermectin 400 µg/kg DRUG

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)

Oral ivermectin 400 µg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Galactosemias

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Giao DO-PHAM, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 22, 2016
• Study Start: October 11, 2017
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

FR (1)