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Efficacy Test on Skin Hydration and Skin Barrier Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305057
First Posted: February 28, 2011
Last Update Posted: February 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Dundee
Information provided by:
Cosmos Technical Center
January 13, 2011
February 28, 2011
February 28, 2011
February 2009
February 2009   (Final data collection date for primary outcome measure)
Measurement of skin surface water content and Trans-Epidermal Water Loss (TEWL) [ Time Frame: Before application, 1 week, 2 week and 4 weeks after application ]
Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation (without P-IP, oil-in-water emulsion type) on the other side twice daily (morning and evening) for 28 days. Skin surface water contents and TEWLs were measured at the time frame described above and the results were analyzed as a change from a value of before-application at each measurement.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy Test on Skin Hydration and Skin Barrier Function
Human Use Test on Skin Hydration and Skin Barrier Function
The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined. Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation on the other side twice daily (morning and evening) for 28 days. All subjects gave written informed consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S. ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.
It is expected that the long-term application of P-IP increase skin surface water contents and suppress TEWL.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Dry Skin
Other: Pyridoxine tri-isopalmitate
2% dosage, oil-in-water emulsion, twice a day, 28 days
Experimental: Evaluation of P-IP on hydration and barrier function
Effects of P-IP on improvement of skin hydration and TEWL were examined.
Intervention: Other: Pyridoxine tri-isopalmitate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy skin

Exclusion Criteria:

  • don't use any moisturizer
Sexes Eligible for Study: All
33 Years to 62 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01305057
Cosmos1
hydration-1 ( Other Identifier: Cosmos Technical Center )
Yes
Not Provided
Not Provided
Hitoshi Masaki, Cosmos Technical Center
Cosmos Technical Center
University of Dundee
Not Provided
Cosmos Technical Center
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP