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Clinical Trial Summary

A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (human head lice).


Clinical Trial Description

This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00545753
Study type Interventional
Source ParaPRO LLC
Contact
Status Completed
Phase Phase 3
Start date September 2007
Completion date May 2008

See also
  Status Clinical Trial Phase
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Completed NCT00752973 - Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice Phase 2/Phase 3
Completed NCT00381082 - A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides. Phase 2/Phase 3
Terminated NCT02499549 - Two Treatment Regimens of Cocamide DEA Lotion for Head Lice Phase 2/Phase 3
Completed NCT05643820 - Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis Phase 1
Completed NCT00731718 - Control of Head Lice Infestations in Children and Adults N/A
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Completed NCT00927407 - Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice Phase 1
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Completed NCT00207753 - Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections N/A
Completed NCT00963508 - Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Phase 3
Completed NCT00927472 - Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Phase 3
Completed NCT01336647 - An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation Phase 2