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CompletedNCT00839280Updated Oct 15, 2014

Moisturizing Effect of Two Dexpanthenol Formulations

A Phase 2 interventional study of Dexpanthenol foam spray, new formulation and Dexpanthenol foam spray, old formulation in Skin Abnormalities, sponsored by Bayer. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-15.

Sponsored by Bayer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Skin Abnormalities

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Keywords

  • Dry skin
  • Dexpanthenol
  • Moisturizing effect
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Dexpanthenol foam spray, new formulation

  • Active comparator
    Arm 2

    Drug: Dexpanthenol foam spray, old formulation

Interventions

  • DrugDexpanthenol foam spray, new formulation

    2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter

  • DrugDexpanthenol foam spray, old formulation

    2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter

05

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Cutaneous hydration rate

    Time frame: 15 min, 30 min, 1h, 2h, 3h, 5h

  2. Incidence of Adverse Events

    Time frame: FPFV - LPLV

06

Study locations

1 site
  • Villeurbanne, 69503, France
07

Registry details

Key details

Study ID
NCT00839280
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Feb 9, 2009
Start date
Aug 2007
Primary completion
Sep 2007
Completion
Sep 2007
Last update
Oct 15, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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