NCT01305057

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
Last Updated

February 28, 2011

Status Verified

February 1, 2011

Enrollment Period

Same day

First QC Date

January 13, 2011

Last Update Submit

February 25, 2011

Conditions

Dry Skin

Keywords

dry skin condition

Outcome Measures

Primary Outcomes (1)

  • Measurement of skin surface water content and Trans-Epidermal Water Loss (TEWL)

    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.

    Before application, 1 week, 2 week and 4 weeks after application

Study Arms (1)

Evaluation of P-IP on hydration and barrier function

EXPERIMENTAL

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

Other: Pyridoxine tri-isopalmitate

Interventions

Pyridoxine tri-isopalmitateOTHER

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

Evaluation of P-IP on hydration and barrier function

Eligibility Criteria

Age33 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy skin

You may not qualify if:

  • don't use any moisturizer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cosmos Technical Center

Itabashi-ku, Tokyo, 174-0046, Japan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2011

First Posted

February 28, 2011

Study Start

February 1, 2009

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 28, 2011

Record last verified: 2011-02

Locations

JP(1)