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Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

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.
 
ClinicalTrials.gov Identifier: NCT00644917
Recruitment Status : Completed
First Posted : March 27, 2008
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Information provided by:
Healthpoint

Study Description
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Brief Summary:
The product is being tested to see if exposure to light causes toxic reactions on the skin.

Condition or disease Intervention/treatment Phase
Healthy Drug: Xenaderm Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment
Study Start Date : February 2008
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Drug
 Drug: Xenaderm
20mg under Finn chambers
Placebo Comparator: B
Placebo comparator
 Drug: Placebo
20mg under Finn chambers
No Intervention: C
Subjects serve as own controls.


Outcome Measures
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Primary Outcome Measures :
  1. Skin Reaction Score [ Time Frame: 48 hours ]
    Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Under 18 years of age
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644917


Sponsors and Collaborators
Healthpoint
Investigators
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Study Director: Innes Cargill, PhD Healthpoint, Ltd.
More Information
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Responsible Party: H. B. Slade, M.D., Healthpoint, Ltd.
ClinicalTrials.gov Identifier: NCT00644917    
Other Study ID Numbers: 011 101 09 001
First Posted: March 27, 2008    Key Record Dates
Results First Posted: January 13, 2014
Last Update Posted: January 13, 2014
Last Verified: December 2013
Keywords provided by Healthpoint:
wound healing
phototoxicity
Healthy Subjects