Moisturizing Effect of Two Dexpanthenol Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00839280
First received: February 6, 2009
Last updated: October 14, 2014
Last verified: October 2014

February 6, 2009
October 14, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: FPFV - LPLV ] [ Designated as safety issue: Yes ]
  • Cutaneous hydration rate measured at [ Time Frame: 15 min, 30 min, 1h, 2h, 3h, 5h ] [ Designated as safety issue: No ]
  • incidence of adverse events [ Time Frame: FPFV - LPLV ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00839280
12040
No
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