NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

NCT00605956 | Completed Phase 1

• 2 other identifiers: SPN-108-08HTR Study #07-128385-111
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Lice

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual grading of test site and assessments of adverse experiences

  Evaluations over a 6 week period

Study Arms (3)

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

NatrOVA Creme Rinse - 1% DRUG

NatrOVA Creme Rinse - 1% spinosad

1

NatrOVA Creme Rinse Vehicle Only DRUG

NatrOVA Creme Rinse Vehicle - no spinosad

2

Blank Patch DRUG

Blank Patch

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ParaPRO LLC: lead

Study Sites (1)

Hill Top Research

St. Petersburg, Florida, 33710, United States

Location

Related Links

• sponsor website

Study Officials

• John V. Murray, MD

  Hill Top Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 1, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 4, 2008

Record last verified: 2008-05

Locations

US (1)