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Efficacy Test on Skin Hydration and Skin Barrier Function

NCT ID: NCT01305057

Last Updated: 2011-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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

Conditions

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Dry Skin

Keywords

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dry skin condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Evaluation of P-IP on hydration and barrier function

Effects of P-IP on improvement of skin hydration and TEWL were examined.

Group Type EXPERIMENTAL

Pyridoxine tri-isopalmitate

Intervention Type OTHER

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

Interventions

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Pyridoxine tri-isopalmitate

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy skin

Exclusion Criteria

* don't use any moisturizer
Minimum Eligible Age

33 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Dundee

OTHER

Sponsor Role collaborator

Cosmos Technical Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Cosmos Technical Center

Locations

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Cosmos Technical Center

Itabashi-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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hydration-1

Identifier Type: OTHER

Identifier Source: secondary_id

Cosmos1

Identifier Type: -

Identifier Source: org_study_id