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NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

Primary Purpose

Head Lice

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NatrOVA Creme Rinse - 1%
NatrOVA Creme Rinse Vehicle Only
Blank Patch
Sponsored by
ParaPRO LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Lice focused on measuring head lice, NatrOVA Creme Rinse - 1% is intended for the treatment of head lice

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hill Top Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

NatrOVA Creme Rinse - 1% Spinosad

NatrOVA Vehicle - no Spinosad

Blank Patch

Outcomes

Primary Outcome Measures

Visual grading of test site and assessments of adverse experiences

Secondary Outcome Measures

Full Information

First Posted
January 21, 2008
Last Updated
July 31, 2008
Sponsor
ParaPRO LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00605956
Brief Title
NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers
Official Title
An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ParaPRO LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Lice
Keywords
head lice, NatrOVA Creme Rinse - 1% is intended for the treatment of head lice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
NatrOVA Creme Rinse - 1% Spinosad
Arm Title
2
Arm Type
Experimental
Arm Description
NatrOVA Vehicle - no Spinosad
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Blank Patch
Intervention Type
Drug
Intervention Name(s)
NatrOVA Creme Rinse - 1%
Intervention Description
NatrOVA Creme Rinse - 1% spinosad
Intervention Type
Drug
Intervention Name(s)
NatrOVA Creme Rinse Vehicle Only
Intervention Description
NatrOVA Creme Rinse Vehicle - no spinosad
Intervention Type
Drug
Intervention Name(s)
Blank Patch
Intervention Description
Blank Patch
Primary Outcome Measure Information:
Title
Visual grading of test site and assessments of adverse experiences
Time Frame
Evaluations over a 6 week period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John V. Murray, MD
Organizational Affiliation
Hill Top Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hill Top Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.parapro.com
Description
sponsor website

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NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

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