Back to resultsMoisturizing Effect of Two Dexpanthenol Formulations
Primary Purpose
Skin Abnormalities
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Dexpanthenol foam spray, new formulation
Dexpanthenol foam spray, old formulation
Sponsored by
About this trial
This is an interventional treatment trial for Skin Abnormalities focused on measuring Dry skin, Dexpanthenol, Moisturizing effect
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h
Secondary Outcome Measures
Cutaneous hydration rate
Incidence of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00839280
Brief Title
Moisturizing Effect of Two Dexpanthenol Formulations
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Abnormalities
Keywords
Dry skin, Dexpanthenol, Moisturizing effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexpanthenol foam spray, new formulation
Intervention Description
2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
Intervention Type
Drug
Intervention Name(s)
Dexpanthenol foam spray, old formulation
Intervention Description
2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
Primary Outcome Measure Information:
Title
Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h
Time Frame
0 min, 15 min, 30 min, 1h, 2h, 3h, 5h
Secondary Outcome Measure Information:
Title
Cutaneous hydration rate
Time Frame
15 min, 30 min, 1h, 2h, 3h, 5h
Title
Incidence of Adverse Events
Time Frame
FPFV - LPLV
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Villeurbanne
ZIP/Postal Code
69503
Country
France
12. IPD Sharing Statement
Learn more about this trial
Moisturizing Effect of Two Dexpanthenol Formulations
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