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Efficacy Test on Skin Hydration and Skin Barrier Function

Human Use Test on Skin Hydration and Skin Barrier Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01305057
Enrollment
20
Registered
2011-02-28
Start date
2009-02-28
Completion date
2009-02-28
Last updated
2011-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Skin

Keywords

dry skin condition

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.

Detailed description

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

Interventions

OTHERPyridoxine tri-isopalmitate

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

Sponsors

University of Dundee
CollaboratorOTHER
Cosmos Technical Center
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
33 Years to 62 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy skin

Exclusion criteria

* don't use any moisturizer

Design outcomes

Primary

MeasureTime frameDescription
Measurement of skin surface water content and Trans-Epidermal Water Loss (TEWL)Before application, 1 week, 2 week and 4 weeks after applicationSubjects 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.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026