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Completed

NCT Number: NCT00262418

Comparison of the Efficacy and Safety of Ivermectin to Permethrin

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

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Key information

Conditions

Scabies Ectoparasitic Infestations Infections Mite Infestations Parasitic Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of ivermectin or permethrin

Drug

Primary outcomes

  1. Clinical healing of the skin injuries

    Time frame: on day28

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Dec 6, 2005
Registry last updated
Dec 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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