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
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
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014