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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 1 Evaluation of the Phototoxic Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Spinosad

U.S. FDA Resources

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
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

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

Additional Information:

sponsor web site This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by ParaPro Pharmacuticals:

Head Lice

ClinicalTrials.gov processed this record on February 12, 2012