Efficacy of Dexpanthenol in Thermic Erythema

October 18, 2013 updated by: Bayer

Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.

The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

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

  • France
      • Villeurbanne, France, 69503

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects
  • Phototype: I to IV according to Fitzpatrick scale

Exclusion Criteria:

  • Pregnant or nursing women
  • Subjects registered as being in exclusion period in the French Health Minister file of subjects
  • Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Dexpanthenol foam spray, new formulation
2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
ACTIVE_COMPARATOR: Arm 2
Drug: Dexpanthenol foam spray, old formulation
2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
Time Frame: 2 min, 5 min, 10 min, 15 min
2 min, 5 min, 10 min, 15 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Skin temperature
Time Frame: 2 min, 5 min, 10 min
2 min, 5 min, 10 min
Evaluation of the cooling/soothing effect (scores) after first and second application
Time Frame: 2 min, 5min, 10 min, 15 min
2 min, 5min, 10 min, 15 min
Evaluation of the foam covering properties after first application
Time Frame: 2 min, 5 min, 10 min, 15 min
2 min, 5 min, 10 min, 15 min
Incidence of adverse events
Time Frame: FPFV - LPLV
FPFV - LPLV

Collaborators and Investigators

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

Sponsor

Bayer

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

September 1, 2007

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (ESTIMATE)

February 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12039

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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