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

Resource links provided by NLM:


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
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

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

ClinicalTrials.gov processed this record on April 17, 2014