Efficacy Test on Skin Hydration and Skin Barrier Function

This study has been completed.
Sponsor:
Collaborator:
University of Dundee
Information provided by:
Cosmos Technical Center
ClinicalTrials.gov Identifier:
NCT01305057
First received: January 13, 2011
Last updated: February 25, 2011
Last verified: February 2011

January 13, 2011
February 25, 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 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01305057 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
33 Years to 62 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01305057
Cosmos1, hydration-1
Yes
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