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Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

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ClinicalTrials.gov Identifier: NCT00645164
Recruitment Status : Completed
First Posted : March 27, 2008
Results First Posted : April 6, 2009
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:
Healthpoint

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

Condition or disease Intervention/treatment Phase
Healthy Other: Ointment Vehicle Drug: Xenaderm Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
Study Start Date : March 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: Xenaderm
Subject serves as own control
Other: Ointment Vehicle
Subject acts as own control. 20 mg under Finn chambers

Drug: Xenaderm
20 mg under Finn chambers




Primary Outcome Measures :
  1. 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.



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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:

  • Less than 18 years

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): NCT00645164


Locations
United States, North Carolina
Suncare Research Laboratories
Winston-Salem, North Carolina, United States
Sponsors and Collaborators
Healthpoint
Investigators
Principal Investigator: Joe Stanfield, PhD Suncare Research Laboratories

Responsible Party: H. B. Slade, MD, Healthpoint
ClinicalTrials.gov Identifier: NCT00645164     History of Changes
Other Study ID Numbers: 011 101 09 002
First Posted: March 27, 2008    Key Record Dates
Results First Posted: April 6, 2009
Last Update Posted: June 8, 2010
Last Verified: June 2010

Keywords provided by Healthpoint:
wound healing
photoallergenicity
Healthy subjects

Additional relevant MeSH terms:
Dermatitis, Photoallergic
Dermatitis, Allergic Contact
Dermatitis, Contact
Dermatitis
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Castor Oil
Cathartics
Gastrointestinal Agents