Moisturizing Effect of Two Dexpanthenol Formulations | NCT00839280

Studies
Moisturizing Effect of Two Dexpanthenol Formulations

NCT00839280

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 15, 2014Estimated

Enrollment

19Actual

Phase

Phase 2

Conditions

Skin Abnormalities

Interventions

Dexpanthenol foam spray, new formulation
Dexpanthenol foam spray, old formulation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Feb 6, 2009

First Submission Date that Met QC Criteria

Feb 6, 2009

First Posted Date

Feb 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2014

Last Update Posted Date

Oct 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Dexpanthenol foam spray, new formulation
Arm 2	Active Comparator		Drug: Dexpanthenol foam spray, old formulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexpanthenol foam spray, new formulation	Drug	2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012868	Skin Abnormalities

Ancestor Terms

ID	Term
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided