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Completed

NCT Number: NCT01305057

Efficacy 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.

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Key information

Conditions

Dry Skin

Age range

33 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cosmos Technical Center

Itabashi-ku, Tokyo, 174-0046, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy skin

Exclusion criteria

  • don't use any moisturizer

Treatment and study plan

Pyridoxine tri-isopalmitate

Other

2% dosage, oil-in-water emulsion, twice a day, 28 days

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cosmos Technical Center

Industry

Collaborators

  • University of Dundee

Registry information

Official study title

Human Use Test on Skin Hydration and Skin Barrier Function

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 28, 2011
Registry last updated
Feb 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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