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Trial record 29 of 103 for:    IVERMECTIN

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

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).

Condition or disease Intervention/treatment Phase
Gale Severe Forms of Scabies Oral Parasitic Drug Ivermectin Drug: Ivermectin 200 µg/kg Drug: Ivermectin 400 µg/kg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies
Drug Information available for: Ivermectin

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

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




Primary Outcome Measures :
  1. 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

  2. Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions [ Time Frame: Days 28+/- 2 days ]

Secondary Outcome Measures :
  1. Rate of adverse effects [ Time Frame: Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841215


Contacts
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Contact: Giao DO-PHAM, MD (0)1 49 81 45 09 ext +33 giao.do-pham@aphp.fr

Locations
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France
Henri Mondor Hospital Not yet recruiting
Creteil, France, 94010
Contact: Laetitia Gregoire, M.Sc    (0) 1 49 81 41 64 ext +33    laetitia.gregoire@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Giao DO-PHAM, MD Assistance Publique - Hôpitaux de Paris

Additional Information:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02841215     History of Changes
Other Study ID Numbers: P140939
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Gale
Severe forms of scabies
Oral parasitic drug
Ivermectin
Additional relevant MeSH terms:
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Ivermectin
Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Emollients
Permethrin
Antiparasitic Agents
Anti-Infective Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action