NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers

Conditions
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Head Lice

Intervention / Treatment
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* Drug: NatrOVA Creme Rinse - 1%
* Drug: NatrOVA Creme Rinse Vehicle Only
* Drug: Blank Patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>NatrOVA Creme Rinse - 1% Spinosad | Drug: NatrOVA Creme Rinse - 1%<br>* NatrOVA Creme Rinse - 1% spinosad<br>|
| Experimental: 2<br>NatrOVA Vehicle - no Spinosad | Drug: NatrOVA Creme Rinse Vehicle Only<br>* NatrOVA Creme Rinse Vehicle - no spinosad<br>|
| Placebo Comparator: 3<br>Blank Patch | Drug: Blank Patch<br>* Blank Patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual grading of test site and assessments of adverse experiences |  | Evaluations over a 6 week period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head lice, NatrOVA Creme Rinse - 1% is intended for the treatment of head lice