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Phototoxicity Potential of NatrOVA Creme Rinse - 1%

NCT ID: NCT00591331

Last Updated: 2008-05-20

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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Conditions

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Head Lice

Keywords

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Head Lice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

NatrOVA Creme Rinse - 1%

Group Type EXPERIMENTAL

Spinosad (the active ingredient in NatrOVA)

Intervention Type DRUG

This is a patch test in which the test material is applied to the patch and the patch applied to the skin.

2

NatrOVA Creme Rinse Vehicle Only

Group Type EXPERIMENTAL

Spinosad (the active ingredient in NatrOVA)

Intervention Type DRUG

This is a patch test in which the test material is applied to the patch and the patch applied to the skin.

3

Blank patch

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. History of severe reactions from exposure to sunlight
2. Known allergies or sensitivities to adhesives in patches
3. Inability to evaluate the skin in and around the test sites
4. Diabetes requiring medication
5. Clinical significant skin disease
6. Asthma or other severe respiratory disease
7. Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
8. History or current skin cancer
9. Mastectomy for cancer involving removal of lymph nodes draining the test sites
10. Epilepsy
11. Pregnancy, lactation, or planned pregnancy during study period
12. Chronic use of systemic antihistamine medication within 14 days of screening
13. Use of anti-inflammatory drugs within 2 days of Screening Visit 1
14. Currently receiving allergy injections
15. Use of immunosuppressive drugs
16. Topical drugs used at the test site within 7 days of Screening Visit 1
17. Current participation in any clinical trial
18. Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
19. Use of any investigational drug therapy within 4 weeks of study start.
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 web site

Other Identifiers

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HTR 07-128384-111

Identifier Type: -

Identifier Source: secondary_id

SPN-107-07

Identifier Type: -

Identifier Source: org_study_id