Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

This study has been completed.
Sponsor:
Information provided by:
Healthpoint
ClinicalTrials.gov Identifier:
NCT00645164
First received: March 24, 2008
Last updated: June 1, 2010
Last verified: June 2010

March 24, 2008
June 1, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00645164 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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: Double Blind (Subject, Caregiver, 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00645164
011 101 09 002
No
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