Moisturizing Effect of Two Dexpanthenol Formulations

October 14, 2014 updated by: Bayer

Evaluation of the Moisturizing Effect of Bepanthen Burn Relief Foam Spray New Formula Versus Bepanthen Burn Relief Foam Spray (Current Formula). Equivalence Trial. Intra-individual Design.

The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects
  • Phototype: I to IV according to Fitzpatrick scale
  • Subjects with dry skin on their forearms

Exclusion Criteria:

  • Pregnant or nursing women
  • Subjects registered as being in exclusion period in the French Health Minister file of subjects
  • Subjects with hypersensitivity to one of the test products

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h
Time Frame: 0 min, 15 min, 30 min, 1h, 2h, 3h, 5h
0 min, 15 min, 30 min, 1h, 2h, 3h, 5h

Secondary Outcome Measures

Outcome Measure
Time Frame
Cutaneous hydration rate
Time Frame: 15 min, 30 min, 1h, 2h, 3h, 5h
15 min, 30 min, 1h, 2h, 3h, 5h
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

August 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 15, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12040

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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