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NCT Number: NCT02841215

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

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).

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Key information

Conditions

Gale Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Carbohydrate Metabolism, Inborn Errors Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Galactosemias Genetic Diseases, Inborn Ivermectin Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Oral Parasitic Drug Severe Forms of Scabies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henri Mondor Hospital

Créteil, 94010, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams

    Time frame: Days 21+/-2 days

    Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days

  2. Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions

    Time frame: Days 28+/- 2 days

Secondary outcomes

  1. Rate of adverse effects

    Time frame: Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: GALECRUSTED

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2016
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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