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NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
ParaPRO LLC
ClinicalTrials.gov Identifier:
NCT00605956
First received: January 21, 2008
Last updated: July 31, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Head Lice
Drug: NatrOVA Creme Rinse - 1%
Drug: NatrOVA Creme Rinse Vehicle Only
Drug: Blank Patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by ParaPRO LLC:

Primary Outcome Measures:
  • Visual grading of test site and assessments of adverse experiences [ Time Frame: Evaluations over a 6 week period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 65
Study Start Date: January 2008
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
NatrOVA Creme Rinse - 1% Spinosad
Drug: NatrOVA Creme Rinse - 1%
NatrOVA Creme Rinse - 1% spinosad
Experimental: 2
NatrOVA Vehicle - no Spinosad
Drug: NatrOVA Creme Rinse Vehicle Only
NatrOVA Creme Rinse Vehicle - no spinosad
Placebo Comparator: 3
Blank Patch
Drug: Blank Patch
Blank Patch

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605956

Locations
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States, 33710
Sponsors and Collaborators
ParaPRO LLC
Investigators
Principal Investigator: John V. Murray, MD Hill Top Research
  More Information

Additional Information:
No publications provided

Responsible Party: William C. Culpepper III, ParaPRO, LLC
ClinicalTrials.gov Identifier: NCT00605956     History of Changes
Other Study ID Numbers: SPN-108-08, HTR Study #07-128385-111
Study First Received: January 21, 2008
Last Updated: July 31, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ParaPRO LLC:
head lice
NatrOVA Creme Rinse - 1% is intended for the treatment of head lice

ClinicalTrials.gov processed this record on November 25, 2014