check_circleStudy Completed

Skin Abnormalities

Bayer Identifier:

12040

ClinicalTrials.gov Identifier:

NCT00839280

EudraCT Number:

Not Available

EU CT Number:

Not Available
Moisturizing effect of two Dexpanthenol formulations

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - Healthy subjects
    - Phototype: I to IV according to Fitzpatrick scale
    - Subjects with dry skin on their forearms
  • - 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

Trial summary

Enrollment Goal
19
Trial Dates
August 2007 - September 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Dermscan - VilleurbanneVILLEURBANNE, 69503, France

Primary Outcome

  • Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h
    date_rangeTime Frame:
    0 min, 15 min, 30 min, 1h, 2h, 3h, 5h
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Cutaneous hydration rate
    date_rangeTime Frame:
    15 min, 30 min, 1h, 2h, 3h, 5h
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of Adverse Events
    date_rangeTime Frame:
    FPFV - LPLV
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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