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OpenTrials
Completed

NCT Number: NCT00605956

NatrOVA Photoallergy Study - NatrOVA Creme Rinse 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.

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Key information

Conditions

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

About this study

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.

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
  • 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.

Treatment and study plan

NatrOVA Creme Rinse - 1%

Drug

NatrOVA Creme Rinse - 1% spinosad

NatrOVA Creme Rinse Vehicle Only

Drug

NatrOVA Creme Rinse Vehicle - no spinosad

Blank Patch

Drug

Blank Patch

Primary outcomes

  1. Visual grading of test site and assessments of adverse experiences

    Time frame: Evaluations over a 6 week period

Sponsors and collaborators

Lead sponsor

ParaPRO LLC

Industry

Registry information

Official study title

An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 1, 2008
Registry last updated
Aug 4, 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.

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