ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Dexpanthenol in Thermic Erythema

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.
ClinicalTrials.gov Identifier: NCT00839462
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
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.
Study Start Date : September 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. Skin temperature [ Time Frame: 2 min, 5 min, 10 min ]
  2. Evaluation of the cooling/soothing effect (scores) after first and second application [ Time Frame: 2 min, 5min, 10 min, 15 min ]
  3. Evaluation of the foam covering properties after first application [ Time Frame: 2 min, 5 min, 10 min, 15 min ]
  4. Incidence of adverse events [ Time Frame: FPFV - LPLV ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00839462     History of Changes
Other Study ID Numbers: 12039
First Posted: February 9, 2009    Key Record Dates
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