Efficacy of Dexpanthenol in Thermic Erythema

Overview

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

Full Title of Study: “Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2007

Interventions

  • Drug: Dexpanthenol foam spray, new formulation
    • 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
  • Drug: Dexpanthenol foam spray, old formulation
    • 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter

Arms, Groups and Cohorts

  • Experimental: Arm 1
  • Active Comparator: Arm 2

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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