Efficacy Test on Skin Hydration and Skin Barrier Function

Dry Skin Clinical Trial

Official title:

Human Use Test on Skin Hydration and Skin Barrier Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305057
• Other study ID #: Cosmos1
• Secondary ID: hydration-1
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: February 25, 2011
• Start date: February 2009
• Est. completion date: February 2009

Study information

• Verified date: February 2011
• Source: Cosmos Technical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 33 Years to 62 Years

Eligibility

Inclusion Criteria:

• healthy skin

Exclusion Criteria:

• don't use any moisturizer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dry Skin

Intervention

Other:
• Pyridoxine tri-isopalmitate
2% dosage, oil-in-water emulsion, twice a day, 28 days

Locations

Country	Name	City	State
Japan	Cosmos Technical Center	Itabashi-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Cosmos Technical Center	University of Dundee

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No