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Moisturizing Effect of Two Dexpanthenol Formulations

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: February 6, 2009
Last updated: October 14, 2014
Last verified: October 2014
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • Cutaneous hydration rate [ Time Frame: 15 min, 30 min, 1h, 2h, 3h, 5h ]
  • Incidence of Adverse Events [ Time Frame: FPFV - LPLV ]

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00839280

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

Additional Information:
Responsible Party: Bayer Identifier: NCT00839280     History of Changes
Other Study ID Numbers: 12040
Study First Received: February 6, 2009
Last Updated: October 14, 2014

Keywords provided by Bayer:
Dry skin
Moisturizing effect

Additional relevant MeSH terms:
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Pantothenic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on April 28, 2017