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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
History of Changes
  Purpose

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.


Condition Intervention
Dry Skin
 Other: Pyridoxine tri-isopalmitate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Human Use Test on Skin Hydration and Skin Barrier Function

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Cosmos Technical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: February 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evaluation of P-IP on hydration and barrier function
Effects of P-IP on improvement of skin hydration and TEWL were examined.
 Other: Pyridoxine tri-isopalmitate
2% dosage, oil-in-water emulsion, twice a day, 28 days

Detailed Description:

It is expected that the long-term application of P-IP increase skin surface water contents and suppress TEWL.

  Eligibility

Ages Eligible for Study:   33 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy skin

Exclusion Criteria:

  • don't use any moisturizer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305057

Locations
Japan
Cosmos Technical Center
Itabashi-ku, Tokyo, Japan, 174-0046
Sponsors and Collaborators
Cosmos Technical Center
University of Dundee
  More Information

No publications provided

Responsible Party: Hitoshi Masaki, Cosmos Technical Center
ClinicalTrials.gov Identifier: NCT01305057     History of Changes
Other Study ID Numbers: Cosmos1, hydration-1
Study First Received: January 13, 2011
Last Updated: February 25, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Cosmos Technical Center:
dry skin condition

Additional relevant MeSH terms:
Pyridoxine
Vitamin B Complex
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013