Phototoxicity Potential of NatrOVA Creme Rinse - 1%

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

Completed

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Key information

Conditions

Head Lice

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hill Top Research

St. Petersburg, Florida, 33710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Spinosad (the active ingredient in NatrOVA)

Drug

This is a patch test in which the test material is applied to the patch and the patch applied to the skin.

Placebo

Drug

Primary outcomes

Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences

Time frame: 7 days

Sponsors and collaborators

Lead sponsor

ParaPRO LLC

Industry

Registry information

Official study title

Phase 1 Evaluation of the Phototoxic Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Jan 11, 2008
Registry last updated: May 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed