We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644917
First Posted: March 27, 2008
Last Update Posted: January 13, 2014
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.
Information provided by:
Healthpoint
  Purpose
The product is being tested to see if exposure to light causes toxic reactions on the skin.

Condition Intervention Phase
Healthy Drug: Xenaderm Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • 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.


Enrollment: 38
Study Start Date: February 2008
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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:

  • Under 18 years of age
  Contacts and Locations
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
Study Director: Innes Cargill, PhD Healthpoint, Ltd.
  More Information

Responsible Party: H. B. Slade, M.D., Healthpoint, Ltd.
ClinicalTrials.gov Identifier: NCT00644917     History of Changes
Other Study ID Numbers: 011 101 09 001
First Submitted: March 24, 2008
First Posted: March 27, 2008
Results First Submitted: October 9, 2013
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