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Efficacy of Dexpanthenol in Thermic Erythema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839462
First Posted: February 9, 2009
Last Update Posted: October 21, 2013
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
  Purpose
The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

Condition Intervention Phase
Erythema 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 (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application [ Time Frame: 2 min, 5 min, 10 min, 15 min ]

Secondary Outcome Measures:
  • Skin temperature [ Time Frame: 2 min, 5 min, 10 min ]
  • Evaluation of the cooling/soothing effect (scores) after first and second application [ Time Frame: 2 min, 5min, 10 min, 15 min ]
  • Evaluation of the foam covering properties after first application [ Time Frame: 2 min, 5 min, 10 min, 15 min ]
  • Incidence of adverse events [ Time Frame: FPFV - LPLV ]

Enrollment: 55
Study Start Date: September 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

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

Exclusion Criteria:

  • Pregnant or nursing women
  • Subjects registered as being in exclusion period in the French Health Minister file of subjects
  • Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested
  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): NCT00839462


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: NCT00839462     History of Changes
Other Study ID Numbers: 12039
First Submitted: February 6, 2009
First Posted: February 9, 2009
Last Update Posted: October 21, 2013
Last Verified: October 2013

Keywords provided by Bayer:
Thermal Erythema
Dexpanthenol
Erythema
Efficacy

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