Phototoxicity Potential of NatrOVA Creme Rinse - 1%

Completed · Phase 1 · Has a placebo group

Conditions studied: Head Lice

In brief

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

Key facts

Study ID

NCT00591331

Run by

ParaPRO LLC

People needed

37

Starts

2007-12-01

Expected to finish

2007-12-01

Last updated by the study team

2008-05-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects 18-65 years of age and in good health.
• Fitzpatrick 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
• Inability to evaluate the skin in and around the test sites
• Diabetes requiring medication
• Clinical significant skin disease
• Asthma or other severe respiratory disease
• Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
• History or current skin cancer
• Mastectomy for cancer involving removal of lymph nodes draining the test sites
• Epilepsy
• Pregnancy, lactation, or planned pregnancy during study period
• Chronic use of systemic antihistamine medication within 14 days of screening
• Use of anti-inflammatory drugs within 2 days of Screening Visit 1
• Currently receiving allergy injections
• Use of immunosuppressive drugs
• Topical drugs used at the test site within 7 days of Screening Visit 1
• Current participation in any clinical trial
• Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
• Use of any investigational drug therapy within 4 weeks of study start.

Where it is running

• Hill Top Research — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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