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Moisturizing Effect of Two Dexpanthenol Formulations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839280
First Posted: February 9, 2009
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
February 6, 2009
February 9, 2009
October 15, 2014
August 2007
September 2007   (Final data collection date for primary outcome measure)
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 ]
Area under curve (AUC) od the cutaneous hydration rate measured with corneometer between T0 and T5h [ Time Frame: 0 min, 15 min, 30 min, 1h, 2h, 3h, 5h ]
Complete list of historical versions of study NCT00839280 on ClinicalTrials.gov Archive Site
  • Cutaneous hydration rate [ Time Frame: 15 min, 30 min, 1h, 2h, 3h, 5h ]
  • Incidence of Adverse Events [ Time Frame: FPFV - LPLV ]
  • Cutaneous hydration rate measured at [ Time Frame: 15 min, 30 min, 1h, 2h, 3h, 5h ]
  • Incidence of Adverse Events [ Time Frame: FPFV - LPLV ]
Not Provided
Not Provided
 
Moisturizing Effect of Two Dexpanthenol Formulations
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Skin Abnormalities
  • Drug: Dexpanthenol foam spray, new formulation
    2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
  • 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
    Intervention: Drug: Dexpanthenol foam spray, new formulation
  • Active Comparator: Arm 2
    Intervention: Drug: Dexpanthenol foam spray, old formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
September 2007
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00839280
12040
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP