NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers - Full Text View

Sponsor:	ParaPro Pharmacuticals
Information provided by:	ParaPro Pharmacuticals
ClinicalTrials.gov Identifier:	NCT00605956

Purpose

Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate sets of patches of test articles are used with exposure of only one set to UV radiation and subsequent evaluation of both sets for skin reactions in order to compare irradiated versus non-irradiated test sites.

Condition	Intervention	Phase
Head Lice	Drug: NatrOVA Creme Rinse - 1% Drug: NatrOVA Creme Rinse Vehicle Only Drug: Blank Patch	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	An Evaluation of the Photoallergy 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:

Visual grading of test site and assessments of adverse experiences [ Time Frame: Evaluations over a 6 week period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	65
Study Start Date:	January 2008
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 NatrOVA Creme Rinse - 1% Spinosad	Drug: NatrOVA Creme Rinse - 1% NatrOVA Creme Rinse - 1% spinosad
Experimental: 2 NatrOVA Vehicle - no Spinosad	Drug: NatrOVA Creme Rinse Vehicle Only NatrOVA Creme Rinse Vehicle - no spinosad
Placebo Comparator: 3 Blank Patch	Drug: Blank Patch Blank Patch

Detailed Description:

The study consists of of following phases: screening, induction, rest, challenge, and re-challenge (if necessary). The study will be conducted as a randomized, evaluator-blind test design.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female subjects 18-65 years of age
Has the ability to understand and has signed a written informed consent form and HIPAA authorization
Females of childbearing potential must agree to use an adequate birth control
Fitzpatrick (1988) skin type I, II, or III.

Exclusion Criteria:

History of severe reactions from exposure to sunlight
Known allergies or sensitivities to adhesives in patches, medical tape, or ingredients found in the test articles
Inability to evaluate the skin in and around the test sites
Diabetes requiring medication
Clinical significant skin diseases which may contraindicate participation
Asthma or any other severe respiratory disease requiring chronic medication
Known immunological disorders such as HIV, AIDS, SLE and/or RA
History, within the last six months, of current cancer, including skin cancer
Mastectomy for cancer removal of lymph nodes draining test sites
Epilepsy
Pregnancy, lactation, or planning a pregnancy during the test period
Chronic use of systemic antihistamine medication, or use within 14 days prior to Screening Visit
Use of anti-inflammatory drugs (exception: acetaminophen and < 81 mg.day aspirin are permitted) within 2 days of Screening Visit
Currently receiving allergy injections
Currently taking or expecting to take any photosensitizing medications
Use of immunosuppressive drugs
Topical drugs used at the test sites within the last 7 days prior to screening
Current participation in any clinical trial
Participation in any patch test for irritation or sensitization or any test involving UV exposures within 4 wees of study start
Use of any investigational therapy within the past 4 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605956

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 website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	William C. Culpepper III, ParaPRO, LLC
ClinicalTrials.gov Identifier:	NCT00605956 History of Changes
Other Study ID Numbers:	SPN-108-08, HTR Study #07-128385-111
Study First Received:	January 21, 2008
Last Updated:	July 31, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by ParaPro Pharmacuticals:

head lice
NatrOVA Creme Rinse - 1% is intended for the treatment of head lice

Additional relevant MeSH terms:

Dermatitis, Photoallergic
Dermatitis, Allergic Contact
Dermatitis, Contact
Dermatitis
Skin Diseases

Photosensitivity Disorders
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012