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Efficacy of Dexpanthenol in Thermic Erythema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00839462
First received: February 6, 2009
Last updated: October 18, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Skin temperature [ Time Frame: 2 min, 5 min, 10 min ] [ Designated as safety issue: No ]
  • Evaluation of the cooling/soothing effect (scores) after first and second application [ Time Frame: 2 min, 5min, 10 min, 15 min ] [ Designated as safety issue: No ]
  • Evaluation of the foam covering properties after first application [ Time Frame: 2 min, 5 min, 10 min, 15 min ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: FPFV - LPLV ] [ Designated as safety issue: Yes ]

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

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

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
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 ClinicalTrials.gov identifier: NCT00839462

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: NCT00839462     History of Changes
Other Study ID Numbers: 12039
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:
Thermal Erythema
Dexpanthenol
Erythema
Efficacy

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

ClinicalTrials.gov processed this record on November 25, 2014