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Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645164
First Posted: March 27, 2008
Last Update Posted: June 8, 2010
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.
Information provided by:
Healthpoint
March 24, 2008
March 27, 2008
October 8, 2008
April 6, 2009
June 8, 2010
March 2008
May 2008   (Final data collection date for primary outcome measure)
Frequency Distribution of Skin Irritation Scores [ Time Frame: 48-hours post irradiation ]
Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.
Skin reaction score [ Time Frame: 3 weeks ]
Complete list of historical versions of study NCT00645164 on ClinicalTrials.gov Archive Site
Not Provided
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Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
The product is being tested to see if exposure to light causes photoallergic reactions on the skin.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy
  • Other: Ointment Vehicle
    Subject acts as own control. 20 mg under Finn chambers
  • Drug: Xenaderm
    20 mg under Finn chambers
Experimental: Xenaderm
Subject serves as own control
Interventions:
  • Other: Ointment Vehicle
  • Drug: Xenaderm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
June 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Less than 18 years
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00645164
011 101 09 002
No
Not Provided
Not Provided
H. B. Slade, MD, Healthpoint
Healthpoint
Not Provided
Principal Investigator: Joe Stanfield, PhD Suncare Research Laboratories
Healthpoint
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP