Comparison of the Efficacy and Safety of Ivermectin to Permethrin

This study has been completed.
Sponsor:
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00262418
First received: December 4, 2005
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University Ghent:

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

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

Enrollment: 160
Study Start Date: July 2004
Study Completion Date: May 2005
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

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00262418     History of Changes
Other Study ID Numbers: 2004/212
Study First Received: December 4, 2005
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014