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NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00605956
Recruitment Status : Completed
First Posted : February 1, 2008
Last Update Posted : August 4, 2008
Sponsor:
Information provided by:
ParaPRO LLC

January 21, 2008
February 1, 2008
August 4, 2008
January 2008
February 2008   (Final data collection date for primary outcome measure)
Visual grading of test site and assessments of adverse experiences [ Time Frame: Evaluations over a 6 week period ]
Same as current
Complete list of historical versions of study NCT00605956 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers
An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Head Lice
  • Drug: NatrOVA Creme Rinse - 1%
    NatrOVA Creme Rinse - 1% spinosad
  • Drug: NatrOVA Creme Rinse Vehicle Only
    NatrOVA Creme Rinse Vehicle - no spinosad
  • Drug: Blank Patch
    Blank Patch
  • Experimental: 1
    NatrOVA Creme Rinse - 1% Spinosad
    Intervention: Drug: NatrOVA Creme Rinse - 1%
  • Experimental: 2
    NatrOVA Vehicle - no Spinosad
    Intervention: Drug: NatrOVA Creme Rinse Vehicle Only
  • Placebo Comparator: 3
    Blank Patch
    Intervention: Drug: Blank Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
Same as current
February 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00605956
SPN-108-08
HTR Study #07-128385-111
No
Not Provided
Not Provided
William C. Culpepper III, ParaPRO, LLC
ParaPRO LLC
Not Provided
Principal Investigator: John V. Murray, MD Hill Top Research
ParaPRO LLC
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP