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NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

NCT ID: NCT00605956

Last Updated: 2008-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-02-29

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.

Conditions

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Head Lice

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

NatrOVA Creme Rinse - 1% Spinosad

Group Type EXPERIMENTAL

NatrOVA Creme Rinse - 1%

Intervention Type DRUG

NatrOVA Creme Rinse - 1% spinosad

2

NatrOVA Vehicle - no Spinosad

Group Type EXPERIMENTAL

NatrOVA Creme Rinse Vehicle Only

Intervention Type DRUG

NatrOVA Creme Rinse Vehicle - no spinosad

3

Blank Patch

Group Type PLACEBO_COMPARATOR

Blank Patch

Intervention Type DRUG

Blank Patch

Interventions

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NatrOVA Creme Rinse - 1%

NatrOVA Creme Rinse - 1% spinosad

Intervention Type DRUG

NatrOVA Creme Rinse Vehicle Only

NatrOVA Creme Rinse Vehicle - no spinosad

Intervention Type DRUG

Blank Patch

Blank Patch

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ParaPRO LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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ParaPRO, LLC

Principal Investigators

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John V. Murray, MD

Role: PRINCIPAL_INVESTIGATOR

Hill Top Research

Locations

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Hill Top Research

St. Petersburg, Florida, United States

Site Status

Countries

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United States

Related Links

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http://www.parapro.com

sponsor website

Other Identifiers

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HTR Study #07-128385-111

Identifier Type: -

Identifier Source: secondary_id

SPN-108-08

Identifier Type: -

Identifier Source: org_study_id