Phototoxicity Potential of NatrOVA Creme Rinse - 1%

NCT00591331 | Completed Phase 1

• 2 other identifiers: SPN-107-07HTR 07-128384-111
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.

Conditions

Head Lice

Keywords

Head Lice

Outcome Measures

Primary Outcomes (1)

• Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences

  7 days

Study Arms (3)

1

EXPERIMENTAL

NatrOVA Creme Rinse - 1%

Drug: Spinosad (the active ingredient in NatrOVA)

2

EXPERIMENTAL

NatrOVA Creme Rinse Vehicle Only

Drug: Spinosad (the active ingredient in NatrOVA)

3

PLACEBO COMPARATOR

Blank patch

Drug: placebo

Interventions

Spinosad (the active ingredient in NatrOVA) DRUG

This is a patch test in which the test material is applied to the patch and the patch applied to the skin.

1; 2

placebo DRUG

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 18-65 years of age and in good health.
• Fitzpatrick skin type I, II or III

You may not qualify if:

• History of severe reactions from exposure to sunlight
• Known allergies or sensitivities to adhesives in patches
• Inability to evaluate the skin in and around the test sites
• Diabetes requiring medication
• Clinical significant skin disease
• Asthma or other severe respiratory disease
• Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
• History or current skin cancer
• Mastectomy for cancer involving removal of lymph nodes draining the test sites
• Epilepsy
• Pregnancy, lactation, or planned pregnancy during study period
• Chronic use of systemic antihistamine medication within 14 days of screening
• Use of anti-inflammatory drugs within 2 days of Screening Visit 1
• Currently receiving allergy injections
• Use of immunosuppressive drugs

Sponsors & Collaborators

• ParaPRO LLC: lead

Study Sites (1)

Hill Top Research

St. Petersburg, Florida, 33710, United States

Location

Related Links

• sponsor web site

MeSH Terms

Interventions

spinosad

Study Officials

• John V Murray, MD

  Hill Top Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 20, 2008

Record last verified: 2007-12

Locations

US (1)