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

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ClinicalTrials.gov Identifier: NCT02841215
Recruitment Status : Unknown
Verified December 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE June 30, 2016
First Posted Date  ICMJE July 22, 2016
Last Update Posted Date December 8, 2016
Study Start Date  ICMJE March 2017
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • Rate of a successful treatment defined by : -Two negative parasitologic or two dermoscopic exams [ Time Frame: Days 21+/-2 days ]
    Parasitologic 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 [ Time Frame: Days 28+/- 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
Rate of adverse effects [ Time Frame: Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies
Official Title  ICMJE A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400 ug/kg Ivermectin Regime in Patients With Crusted Scabies as Compared to a 200 ug/kg
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Gale
  • Severe Forms of Scabies
  • Oral Parasitic Drug
  • Ivermectin
Intervention  ICMJE
  • Drug: Ivermectin 200 µg/kg
    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)
  • Drug: Ivermectin 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)
Study Arms  ICMJE
  • Experimental: Oral ivermectin 400 µg/kg
    Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)
    Intervention: Drug: Ivermectin 400 µg/kg
  • Active Comparator: Oral ivermectin 200 µg/kg
    Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)
    Intervention: Drug: Ivermectin 200 µg/kg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 19, 2016)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

  1. clinical criteria :

    • crusted scabies: hyperkeratosis dermatosis of the hands, feet and
    • profuse scabies : erythematous scaly eruption of the neck, face and trunk
  2. paraclinical criteria:

    • Positive parasitological test with > 10 mites per exam
    • or dermoscopic exam with signs of scabies Consent from patient or his/her legal representant, trustworthy person or family member

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream
  • Use of anti parasitological drug (ivermectin or albendazole) within the past 7 days
  • Participation in other biomedical drug research
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02841215
Other Study ID Numbers  ICMJE P140939
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giao DO-PHAM, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP