NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

Head Lice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605956
• Other study ID #: SPN-108-08
• Secondary ID: HTR Study #07-12
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2008
• Last updated: July 31, 2008
• Start date: January 2008
• Est. completion date: February 2008

Study information

• Verified date: May 2008
• Source: ParaPRO LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head Lice

Intervention

Drug:
• NatrOVA Creme Rinse - 1%
NatrOVA Creme Rinse - 1% spinosad
• NatrOVA Creme Rinse Vehicle Only
NatrOVA Creme Rinse Vehicle - no spinosad
• Blank Patch
Blank Patch

Locations

Country	Name	City	State
United States	Hill Top Research	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ParaPRO LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual grading of test site and assessments of adverse experiences		Evaluations over a 6 week period	Yes

External Links

•   sponsor website