Working… Menu

NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00605956
Recruitment Status : Completed
First Posted : February 1, 2008
Last Update Posted : August 4, 2008
Information provided by:

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
Study Start Date : January 2008
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Visual grading of test site and assessments of adverse experiences [ Time Frame: Evaluations over a 6 week period ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00605956

Layout table for location information
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States, 33710
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: John V. Murray, MD Hill Top Research

Additional Information:
Layout table for additonal information
Responsible Party: William C. Culpepper III, ParaPRO, LLC Identifier: NCT00605956     History of Changes
Other Study ID Numbers: SPN-108-08
HTR Study #07-128385-111
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: August 4, 2008
Last Verified: May 2008
Keywords provided by ParaPRO LLC:
head lice
NatrOVA Creme Rinse - 1% is intended for the treatment of head lice
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Photoallergic
Dermatitis, Allergic Contact
Dermatitis, Contact
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Immune System Diseases