Phototoxicity Potential of NatrOVA Creme Rinse - 1%

Phase 1 Evaluation of the Phototoxic Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Head Lice
• Intervention / Treatment: Drug: placebo; Drug: Spinosad (the active ingredient in NatrOVA)

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33710
      • Hill Top Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; NatrOVA Creme Rinse - 1%	Drug: Spinosad (the active ingredient in NatrOVA); This is a patch test in which the test material is applied to the patch and the patch applied to the skin.
Experimental: 2; NatrOVA Creme Rinse Vehicle Only	Drug: Spinosad (the active ingredient in NatrOVA); This is a patch test in which the test material is applied to the patch and the patch applied to the skin.
Placebo Comparator: 3; Blank patch	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences	7 days

Collaborators and Investigators

• Sponsor: ParaPRO LLC
• Investigators: Principal Investigator: John V Murray, MD, Hill Top Research

Publications and helpful links

Helpful Links

• sponsor web site

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: January 10, 2008
• First Posted (Estimate): January 11, 2008

Study Record Updates

• Last Update Posted (Estimate): May 20, 2008
• Last Update Submitted That Met QC Criteria: May 16, 2008
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Head Lice
• Other Study ID Numbers: SPN-107-07; HTR 07-128384-111