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
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 April 16, 2014