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Comparison of the Efficacy and Safety of Ivermectin to Permethrin

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ClinicalTrials.gov Identifier: NCT00262418
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies

Condition or disease Intervention/treatment Phase
Scabies Drug: Administration of ivermectin or permethrin Phase 2

Detailed Description:
Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Double Dummy Study to Compare the Efficacy and Safety of a Single Administration of Ivermectin to a Single Administration of Permethrin for the Treatment of Scabies
Study Start Date : July 2004
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Clinical healing of the skin injuries [ Time Frame: on day28 ]

Secondary Outcome Measures :
  1. Decrease of itching [ Time Frame: on day28 ]
  2. Amelioration of the life quality [ Time Frame: on day28 ]
  3. Number and gravity of adverse events

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

At least one of the following inclusion criteria:

  • Scabies tunnels
  • Positive microscopic examination (acarids, faeces or ova)

At least two of the three following inclusion criteria:

  • Non-specific injuries with a typical distribution pattern
  • Serious itching which increases during the night
  • Family or contacts with similar complaints

Exclusion Criteria:

  • Treatment for scabies < 4 weeks ago
  • Treatment with corticoids < 1 week ago
  • Pregnancy
  • Breast-feeding
  • HIV
  • Serious immunodepressive patients
  • Sensitivity or allergy to one of the components of the study medication
  • Damage of the central nerve system
Contacts and Locations

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): NCT00262418


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Jean-Marie Naeyaert, MD, PhD University Hospital, Ghent
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00262418     History of Changes
Other Study ID Numbers: 2004/212
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Ivermectin
Permethrin
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action