Comparison of the Efficacy and Safety of Ivermectin to Permethrin

• Sponsor: University Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT00262418
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 16

Study Details

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
• 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: Jul 1, 2004
• Actual Study Completion Date: May 1, 2005

Outcome Measures

Primary Outcome Measures

1. Clinical healing of the skin injuries [on day28]

Secondary Outcome Measures

1. Decrease of itching [on day28]

2. Amelioration of the life quality [on day28]

3. Number and gravity of adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Ghent

Investigators

• Principal Investigator: Jean-Marie Naeyaert, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the University Hospital Ghent

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00262418
• Other Study ID Numbers: 2004/212
• First Posted: Dec 6, 2005
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Scabies; Ivermectin; Permethrin

Study Results

No Results Posted as of Dec 28, 2007