Phototoxicity Potential of NatrOVA Creme Rinse - 1% - Full Text View

Purpose

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

Condition	Intervention	Phase
Head Lice	Drug: Spinosad (the active ingredient in NatrOVA) Drug: placebo	Phase I

ChemIDplus related topics:

Spinosad

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

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

Further study details as provided by ParaPro Pharmacuticals:

Primary Outcome Measures:

Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment:	37
Study Start Date:	December 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Placebo Comparator Blank patch	Drug: placebo

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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
Topical drugs used at the test site within 7 days of Screening Visit 1
Current participation in any clinical trial
Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
Use of any investigational drug therapy within 4 weeks of study start.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591331

Locations


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

Sponsors and Collaborators

ParaPro Pharmacuticals

Investigators


Principal Investigator:	John V Murray, MD	Hill Top Research

More Information

sponsor web site This link exits the ClinicalTrials.gov site

Responsible Party:	ParaPRO, LLC ( David C. Rowe )
Study ID Numbers:	SPN-107-07, HTR 07-128384-111
First Received:	December 28, 2007
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00591331
Health Authority:	United States: Food and Drug Administration

Keywords provided by ParaPro Pharmacuticals:

Head Lice

Study placed in the following topic categories:

Lice Infestations

Healthy

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	ParaPro Pharmacuticals
Information provided by:	ParaPro Pharmacuticals
ClinicalTrials.gov Identifier:	NCT00591331