Moisturizing Effect of Two Dexpanthenol Formulations

Phase 2

Completed

• Conditions: Skin Abnormalities
• Interventions: Drug: Dexpanthenol foam spray, old formulation; Drug: Dexpanthenol foam spray, new formulation

• Registration Number: NCT00839280
• Lead Sponsor: Bayer

Brief Summary

The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Dexpanthenol foam spray, old formulation	-
Arm 1	Dexpanthenol foam spray, new formulation	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Cutaneous hydration rate	15 min, 30 min, 1h, 2h, 3h, 5h
Incidence of Adverse Events	FPFV - LPLV