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 18, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Skin Abnormalities
Drug: Dexpanthenol foam spray, new formulation
Drug: Dexpanthenol foam spray, old formulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: August 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839280

Locations
France
Villeurbanne, France, 69503
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00839280     History of Changes
Other Study ID Numbers: 12040
Study First Received: February 6, 2009
Last Updated: October 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Bayer:
Dry skin
Dexpanthenol
Moisturizing effect

Additional relevant MeSH terms:
Congenital Abnormalities
Skin Abnormalities
Skin Diseases
Pantothenic Acid
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014