Phototoxicity Potential of NatrOVA Creme Rinse - 1%

Phase 1

Completed

• Conditions: Head Lice
• Interventions: Drug: Spinosad (the active ingredient in NatrOVA); Drug: placebo

• Registration Number: NCT00591331
• Lead Sponsor: ParaPRO LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-12
• Study Start: 2007-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Last Update Submitted: 2008-05-16
• Last Update Posted: 2008-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

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

Exclusion Criteria

1. History of severe reactions from exposure to sunlight
2. Known allergies or sensitivities to adhesives in patches
3. Inability to evaluate the skin in and around the test sites
4. Diabetes requiring medication
5. Clinical significant skin disease
6. Asthma or other severe respiratory disease
7. Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
8. History or current skin cancer
9. Mastectomy for cancer involving removal of lymph nodes draining the test sites
10. Epilepsy
11. Pregnancy, lactation, or planned pregnancy during study period
12. Chronic use of systemic antihistamine medication within 14 days of screening
13. Use of anti-inflammatory drugs within 2 days of Screening Visit 1
14. Currently receiving allergy injections
15. Use of immunosuppressive drugs
16. Topical drugs used at the test site within 7 days of Screening Visit 1
17. Current participation in any clinical trial
18. Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
19. Use of any investigational drug therapy within 4 weeks of study start.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Spinosad (the active ingredient in NatrOVA)	NatrOVA Creme Rinse Vehicle Only
1	Spinosad (the active ingredient in NatrOVA)	NatrOVA Creme Rinse - 1%
3	placebo	Blank patch

Primary Outcome Measures

Name	Time	Method
Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences	7 days

Trial Locations

Locations (1)

Hill Top Research; 🇺🇸 St. Petersburg, Florida, United States