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
  Purpose

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


Condition Intervention Phase
Healthy
Other: Ointment Vehicle
Drug: Xenaderm
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • 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.


Enrollment: 59
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Less than 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: H. B. Slade, MD, Healthpoint
ClinicalTrials.gov Identifier: NCT00645164     History of Changes
Other Study ID Numbers: 011 101 09 002
Study First Received: March 24, 2008
Results First Received: October 8, 2008
Last Updated: June 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Healthpoint:
wound healing
photoallergenicity
Healthy subjects

ClinicalTrials.gov processed this record on October 01, 2014