Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

This study has been completed.
Sponsor:
Information provided by:
Healthpoint
ClinicalTrials.gov Identifier:
NCT00644917
First received: March 24, 2008
Last updated: December 11, 2013
Last verified: December 2013
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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

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

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Under 18 years of age
  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: NCT00644917

Sponsors and Collaborators
Healthpoint
Investigators
Study Director: Innes Cargill, PhD Healthpoint, Ltd.
  More Information

No publications provided

Responsible Party: H. B. Slade, M.D., Healthpoint, Ltd.
ClinicalTrials.gov Identifier: NCT00644917     History of Changes
Other Study ID Numbers: 011 101 09 001
Study First Received: March 24, 2008
Results First Received: October 9, 2013
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Healthpoint:
wound healing
phototoxicity
Healthy Subjects

ClinicalTrials.gov processed this record on August 28, 2014