Safety and Efficacy Study of NatrOVA - 1% Creme Rinse and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
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).
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, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Pediculosis Capitis(Head Lice)
Intervention
Spinosad Creme Rinse, Spinosad Creme Rinse, Permethrin 1%
Location
Hill Top Research
Scottsdale
Arizona
United States
85251
Status
Completed
Source
ParaPro Pharmacuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00545753
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Dental Waste
Any waste product generated by a dental office, surgery, clinic, or laboratory including amalgams, saliva, and rinse water.
Permethrin
A pyrethroid insecticide commonly used in the treatment of LICE INFESTATIONS and SCABIES.
Clinical Trials
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 Pedicul...
A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis
Phototoxicity Potential of NatrOVA Creme Rinse - 1%
This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.
This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an investigational treatment for head lice and nits, in normal, healthy infants.
NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers
Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, ther...
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