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NCT00839462 Clinical Trial

Efficacy of Dexpanthenol in Thermic Erythema

Erythema Clinical Trial

Official title:
Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00839462
Other study ID # 12039
Secondary ID
Status Completed
Phase Phase 2
First received February 6, 2009
Last updated October 18, 2013
Start date September 2007
Est. completion date September 2007

Study information
Verified date October 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application 2 min, 5 min, 10 min, 15 min Yes
Secondary Skin temperature 2 min, 5 min, 10 min No
Secondary Evaluation of the cooling/soothing effect (scores) after first and second application 2 min, 5min, 10 min, 15 min No
Secondary Evaluation of the foam covering properties after first application 2 min, 5 min, 10 min, 15 min No
Secondary Incidence of adverse events FPFV - LPLV Yes
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