A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age

NCT00410709 | Completed Phase 1

• 1 other identifier: SPN-106-06
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediculosis Capitis (Head Lice)

Keywords

Pediculosis Capitis; Head Lice; Crawlers; Ova; Nits

Outcome Measures

Primary Outcomes (1)

• Safety: Frequency of Adverse events and scalp evaluations for irritation

  4 hours

Interventions

NatrOVA Creme Rinse (1%) DRUG

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, 6 to 24 months of age
• Individuals in good general health, free of any systemic or dermatologic disorders which will interfere with the study results.
• Completion of an appropriate Informed Consent Agreement.
• Subjects must be available to stay in the clinic for blood draws. Parents or guardians must be available to stay in the clinic with the minor subject, for the duration of the study.
• Subjects must have veins capable of withstanding multiple blood draws.
• Normal values (at screening) for serum chemistry and hematology for subjects.

You may not qualify if:

• History of irritation or sensitivity to pediculicide or hair care products or ingredients.
• History of known allergy or sensitivity to topical anesthetics including lidocaine and prilocaine.
• Systemic diseases that could interfere with the results of this study.
• Any condition or illness that, in the opinion of the Principal Investigator or designee, may compromise the objectivity of the protocol or the safety of the subject.
• The use of antibiotics or other systemic medications within two weeks of the screening visit, which in the opinion of the investigator, could interfere with the outcome of the study.
• Participation in a previous drug study within the past 30 days.
• Individuals with any visible skin/scalp condition at the treatment site which will interfere with the evaluations according to the opinion of the Investigator.
• Parents or guardians who, in the opinion of the Investigator, do not understand their child's requirements for study participation and/or may be likely to exhibit poor compliance.

Sponsors & Collaborators

• ParaPRO LLC: lead

Study Sites (1)

Hill Top Research

St. Petersburg, Florida, 33710, United States

Location

Study Officials

• Michael Brown, MD

  Hill Top Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 13, 2006
• Study Start: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: August 1, 2008

Record last verified: 2008-07

Locations

US (1)