Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

December 11, 2013 updated by: Healthpoint
The product is being tested to see if exposure to light causes toxic reactions on the skin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthpoint

Investigators

  • Study Director: Innes Cargill, PhD, Healthpoint, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 011 101 09 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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