Phototoxicity Potential of NatrOVA Creme Rinse - 1% - Tabular View

Tracking Information

First Received Date ^ICMJE

December 28, 2007

Last Updated Date

May 16, 2008

Start Date ^ICMJE

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00591331 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phototoxicity Potential of NatrOVA Creme Rinse - 1%

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Head Lice

Intervention ^ICMJE

Drug: Spinosad (the active ingredient in NatrOVA)
Drug: placebo

Study Arms / Comparison Groups

Experimental: NatrOVA Creme Rinse - 1%
Experimental: NatrOVA Creme Rinse Vehicle Only
Placebo Comparator: Blank patch

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00591331

Responsible Party

David C. Rowe, ParaPRO, LLC

Study ID Numbers ^ICMJE

SPN-107-07, HTR 07-128384-111

Study Sponsor ^ICMJE

ParaPro Pharmacuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

John V Murray, MD

Hill Top Research

Information Provided By

ParaPro Pharmacuticals

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP