We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Human Use Test on Skin Hydration and Skin Barrier Function

Resource links provided by NLM:


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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   33 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy skin

Exclusion Criteria:

  • don't use any moisturizer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305057


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

Responsible Party: Hitoshi Masaki, Cosmos Technical Center
ClinicalTrials.gov Identifier: NCT01305057     History of Changes
Other Study ID Numbers: Cosmos1
hydration-1 ( Other Identifier: Cosmos Technical Center )
First Submitted: January 13, 2011
First Posted: February 28, 2011
Last Update Posted: February 28, 2011
Last Verified: February 2011

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