Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phototoxicity Potential of NatrOVA Creme Rinse - 1%

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.
ClinicalTrials.gov Identifier: NCT00591331
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : May 20, 2008
Sponsor:
Information provided by:
ParaPRO LLC

Brief Summary:
This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.

Condition or disease Intervention/treatment Phase
Head Lice Drug: Spinosad (the active ingredient in NatrOVA) Drug: placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Evaluation of the Phototoxic Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
Study Start Date : December 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Experimental: 1
NatrOVA Creme Rinse - 1%
Drug: Spinosad (the active ingredient in NatrOVA)
This is a patch test in which the test material is applied to the patch and the patch applied to the skin.

Experimental: 2
NatrOVA Creme Rinse Vehicle Only
Drug: Spinosad (the active ingredient in NatrOVA)
This is a patch test in which the test material is applied to the patch and the patch applied to the skin.

Placebo Comparator: 3
Blank patch
Drug: placebo



Primary Outcome Measures :
  1. Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences [ Time Frame: 7 days ]


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
Criteria

Inclusion Criteria:

  1. Male or female subjects 18-65 years of age and in good health.
  2. Fitzpatrick skin type I, II or III

Exclusion Criteria:

  1. History of severe reactions from exposure to sunlight
  2. Known allergies or sensitivities to adhesives in patches
  3. Inability to evaluate the skin in and around the test sites
  4. Diabetes requiring medication
  5. Clinical significant skin disease
  6. Asthma or other severe respiratory disease
  7. Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
  8. History or current skin cancer
  9. Mastectomy for cancer involving removal of lymph nodes draining the test sites
  10. Epilepsy
  11. Pregnancy, lactation, or planned pregnancy during study period
  12. Chronic use of systemic antihistamine medication within 14 days of screening
  13. Use of anti-inflammatory drugs within 2 days of Screening Visit 1
  14. Currently receiving allergy injections
  15. Use of immunosuppressive drugs
  16. Topical drugs used at the test site within 7 days of Screening Visit 1
  17. Current participation in any clinical trial
  18. Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
  19. Use of any investigational drug therapy within 4 weeks of study start.

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 ClinicalTrials.gov identifier (NCT number): NCT00591331


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

Additional Information:
Layout table for additonal information
Responsible Party: David C. Rowe, ParaPRO, LLC
ClinicalTrials.gov Identifier: NCT00591331     History of Changes
Other Study ID Numbers: SPN-107-07
HTR 07-128384-111
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: December 2007

Keywords provided by ParaPRO LLC:
Head Lice