Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Johnson & Johnson Consumer & Personal Products Worldwide |
---|---|
Information provided by: | Johnson & Johnson Consumer & Personal Products Worldwide |
ClinicalTrials.gov Identifier: | NCT00819520 |
The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who have recently used standard head lice treatments without success.
Condition | Intervention | Phase |
---|---|---|
Lice Infestations |
Drug: ivermectin Drug: malathion |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Multicentre Study to Compare the Efficacy and Tolerability of Oral Ivermectin to Malathion 0.5% Lotion in the Treatment of Head Lice Infestation |
Enrollment: | 812 |
Study Start Date: | February 2004 |
Study Completion Date: | October 2004 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
ivermectin Stromectol®)
|
Drug: ivermectin
Two single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion
|
2: Active Comparator
malathion(Prioderm®)
|
Drug: malathion
Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets
|
Head lice infestation occurs frequently, primarily in children 3 to 11 years of age. In recent years an increasing prevalence of lice infestation in schools, day care centres, and summer day camps is believed to be partly due to increasing lice resistance to currently available standard treatments for pediculosis (infestation with lice). There is a need for new effective backup treatments for this common condition of head lice infestation. This is a double-blind, randomized, parallel-group, study in several clinical centres comparing ivermectin as tablets to malathion 0.5% lotion in the treatment of head lice. All enrolled patients participate in the primary phase of the study up to the Day 15 evaluation. Patients who are still infested with lice at Day 15 (treatment failures) will enter an extension phase and be treated in a double-blind, fashion with the opposite treatment (ie ivermectin or malathion). The study hypothesis is that ivermectin will be more effective than malathion in clearing head lice infestation , as measured by the proportion of patients who are lice-free at Study Day 15.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France, Paris | |
Hopital Avicenne | |
Bobigny, Paris, France, 93009 | |
Ireland, Co. Cork | |
Shandon Clinic | |
Cork, Co. Cork, Ireland | |
Israel | |
Chaim Sheba Medical Centre | |
Tel Hashomer, Israel, 52621 | |
United Kingdom, Berks | |
Synexus Clinical Research Centre | |
Reading, Berks, United Kingdom, RG2 7AG |
Study Director: | Jerry Cottrell | J&J Consumer and Personal Products Worldwide |
Responsible Party: | J&J Consumer and Personal Products Worldwide ( Joyce Hauze/Senior Project Manager, Clinical Operations ) |
Study ID Numbers: | 075-00 |
Study First Received: | January 8, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819520 |
Health Authority: | France: Direction Générale de la Santé; Ireland: Irish Medicines Board; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Israel: Ministry of Health |
pediculosis capitis pediculus |
Lice Infestations Skin Diseases, Infectious Skin Diseases |
Ivermectin Parasitic Diseases Malathion |
Cholinesterase Inhibitors Anti-Infective Agents Ectoparasitic Infestations Neurotransmitter Agents Antiparasitic Agents Molecular Mechanisms of Pharmacological Action |
Skin Diseases, Parasitic Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Cholinergic Agents Pharmacologic Actions |