Moisturizing Effect of Two Dexpanthenol Formulations

Skin Abnormalities Clinical Trial

Official title:

Evaluation of the Moisturizing Effect of Bepanthen Burn Relief Foam Spray New Formula Versus Bepanthen Burn Relief Foam Spray (Current Formula). Equivalence Trial. Intra-individual Design.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839280
• Other study ID #: 12040
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2009
• Last updated: October 14, 2014
• Start date: August 2007
• Est. completion date: September 2007

Study information

• Verified date: October 2014
• 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 moisturizing effect of two different Dexpanthenol formulations

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• 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

• Subjects with dry skin on their forearms

Exclusion Criteria:

• Pregnant or nursing women

• Subjects registered as being in exclusion period in the French Health Minister file of subjects

• Subjects with hypersensitivity to one of the test products

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

• Skin Abnormalities

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	Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h		0 min, 15 min, 30 min, 1h, 2h, 3h, 5h	Yes
Secondary	Cutaneous hydration rate		15 min, 30 min, 1h, 2h, 3h, 5h	No
Secondary	Incidence of Adverse Events		FPFV - LPLV	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer Healthcare products.