NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers
Summary
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, therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate sets of patches of test articles are used with exposure of only one set to UV radiation and subsequent evaluation of both sets for skin reactions in order to compare irradiated versus non-irradiated test sites.
Description
The study consists of of following phases: screening, induction, rest, challenge, and re-challenge (if necessary). The study will be conducted as a randomized, evaluator-blind test design.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Head Lice
Intervention
NatrOVA Creme Rinse - 1%, NatrOVA Creme Rinse Vehicle Only, Blank Patch
Location
Hill Top Research
St. Petersburg
Florida
United States
33710
Status
Completed
Source
ParaPro Pharmacuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00605956
- 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.
Ambulances
A vehicle equipped for transporting patients in need of emergency care.
Chemoembolization, Therapeutic
Administration of antineoplastic agents together with an embolizing vehicle. This allows slow release of the agent as well as obstruction of the blood supply to the neoplasm.
Povidone
A polyvinyl polymer of variable molecular weight; used as suspending and dispersing agent and vehicle for pharmaceuticals; also used as blood volume expander.
Automobiles
A usually four-wheeled automotive vehicle designed for passenger transportation and commonly propelled by an internal-combustion engine using a volatile fuel. (Webster, 1973)
Clinical Trials
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.
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 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...
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