NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healt... | NCT00605956

Studies
NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

NCT00605956

Sponsor

ParaPRO LLC

Status

Completed

Last Update Posted

Aug 4, 2008Estimated

Enrollment

65Estimated

Phase

Phase 1

Conditions

Head Lice

Interventions

NatrOVA Creme Rinse - 1%
NatrOVA Creme Rinse Vehicle Only
Blank Patch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HTR Study #07-128385-111

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Jan 21, 2008

First Submission Date that Met QC Criteria

Jan 31, 2008

First Posted Date

Feb 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2008

Last Update Posted Date

Aug 4, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	NatrOVA Creme Rinse - 1% Spinosad	Drug: NatrOVA Creme Rinse - 1%
2	Experimental	NatrOVA Vehicle - no Spinosad	Drug: NatrOVA Creme Rinse Vehicle Only
3	Placebo Comparator	Blank Patch	Drug: Blank Patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NatrOVA Creme Rinse - 1%	Drug	NatrOVA Creme Rinse - 1% spinosad	1

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

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided