This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: Quadruple (Participant, Care Provider, 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 ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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

ClinicalTrials.gov processed this record on August 23, 2017