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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

December 4, 2005
December 19, 2007
July 2004
Not Provided
Clinical healing of the skin injuries [ Time Frame: on day28 ]
Clinical healing of the skin injuries on day28
Complete list of historical versions of study NCT00262418 on ClinicalTrials.gov Archive Site
  • Decrease of itching [ Time Frame: on day28 ]
  • Amelioration of the life quality [ Time Frame: on day28 ]
  • Number and gravity of adverse events
  • Decrease of itching on day28
  • Amelioration of the life quality on day28
  • Number and gravity of adverse events
Not Provided
Not Provided
 
Comparison of the Efficacy and Safety of Ivermectin to Permethrin
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

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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Scabies
Drug: Administration of ivermectin or permethrin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
May 2005
Not Provided

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
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00262418
2004/212
No
Not Provided
University Ghent
Not Provided
Principal Investigator: Jean-Marie Naeyaert, MD, PhD University Hospital, Ghent
University Ghent
December 2007

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