UVB Model Validation Study

July 12, 2010 updated by: X-pert Med GmbH

Single Centre, Subject and Observer Blinded, Placebo Controlled, Cross-over Study of the Effect of Oral Ibuprofen and Topical Hydrocortisone-21-acetate on Ultraviolet Radiation (UVR) Induced Pain and Inflammation in Healthy Volunteers

Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.

Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema doses (MEDs). Read out to determine MED will be done within 24 h after UVR.

A training session (without study medication) using the MED definition areas will be performed in order to introduce subjects to the testing and rating procedures.

Subjects will come in within 14 days of screening to start the first Segment of the study. Eligible subjects will be randomised to receive either:

  1. IB 600 mg, applied orally b.i.d., or
  2. OP, applied orally b.i.d.

Allocation of topical treatment to these areas will be randomly assigned to:

  1. PG, 15 μl/cm2 applied topically b.i.d., or
  2. HC, 15 μl/cm2 applied topically b.i.d.

Defined areas will be irradiated with defined dosages of UVR. Assessment of hyperalgesia to heat and signs of inflammation (erythema, skin temperature) for all areas will be performed.

Subjects return within 4 to 11 days to the study site for the second segment of the study. Treatment allocation will be crossed-over and new treatment areas will be selected on the back.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Graefelfing, Bavaria, Germany, 82166
        • X-pert Med GmbH

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 to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

-

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
Drug: Ibuprofen, Hydrocortisone
Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
Other: Group B
Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
Drug: Hydrocortisone
Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hyperalgesia to heat
Time Frame: 72 h
72 h

Secondary Outcome Measures

Outcome Measure
Time Frame
Erythema, Skin temperature
Time Frame: 72 h
72 h

Collaborators and Investigators

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

Sponsor

X-pert Med GmbH

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

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (Estimate)

January 25, 2010

Study Record Updates

Last Update Posted (Estimate)

July 13, 2010

Last Update Submitted That Met QC Criteria

July 12, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XPM-024

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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