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Moisturizing Effect of Two Dexpanthenol Formulations

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ClinicalTrials.gov Identifier: NCT00839280
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations

Condition or disease Intervention/treatment Phase
Skin Abnormalities Drug: Dexpanthenol foam spray, new formulation Drug: Dexpanthenol foam spray, old formulation Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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.
Study Start Date : August 2007
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839280


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00839280     History of Changes
Other Study ID Numbers: 12040
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014

Keywords provided by Bayer:
Dry skin
Dexpanthenol
Moisturizing effect

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