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Trial record 2 of 50 for:    ( Map: Gabon )

Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04205669
Recruitment Status : Completed
First Posted : December 19, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborators:
Bernhard Nocht Institute for Tropical Medicine
University Hospital Tuebingen
Medical University of Vienna
Information provided by (Responsible Party):
Julian Matthewman, Centre de Recherche Médicale de Lambaréné

Tracking Information
First Submitted Date  ICMJE December 18, 2019
First Posted Date  ICMJE December 19, 2019
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE October 4, 2018
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
Clinical cure [ Time Frame: after 28 days from baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
Proportion of affected household members per household [ Time Frame: after 28 days from baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
Official Title  ICMJE A Randomized Controlled Trial Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
Brief Summary

It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study therefore compares these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné and surroundings in Gabon.

Subjects presenting with uncomplicated scabies are randomized into either the Individual Treatment group, where only the affected subjects receive treatment, or the Household Treatment group, where all family members are treated in parallel to the affected subjects regardless of signs and symptoms. The primary endpoint is clinical cure after 28 days; the secondary endpoint is the proportion of affected household members per household after 28 days.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Scabies
  • Households
Intervention  ICMJE Drug: Benzyl Benzoate 25% Topical Application Lotion
Applied to skin for the treatment of scabies
Study Arms  ICMJE
  • Active Comparator: Individual Treatment
    Intervention: Drug: Benzyl Benzoate 25% Topical Application Lotion
  • Active Comparator: Household Treatment
    Intervention: Drug: Benzyl Benzoate 25% Topical Application Lotion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2019)
104
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 21, 2019
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosed with active, uncomplicated scabies
  • no known hypersensitivity or allergy against benzyl benzoate

Exclusion Criteria:

  • hypersensitivity or allergy against benzyl benzoate
  • severe superinfection of scabies lesions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Gabon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04205669
Other Study ID Numbers  ICMJE GrattiGratta31082018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Julian Matthewman, Centre de Recherche Médicale de Lambaréné
Study Sponsor  ICMJE Centre de Recherche Médicale de Lambaréné
Collaborators  ICMJE
  • Bernhard Nocht Institute for Tropical Medicine
  • University Hospital Tuebingen
  • Medical University of Vienna
Investigators  ICMJE Not Provided
PRS Account Centre de Recherche Médicale de Lambaréné
Verification Date December 2019

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