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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
|Official Title:||Human Use Test on Skin Hydration and Skin Barrier Function|
- 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2009|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Evaluation of P-IP on hydration and barrier function
Effects of P-IP on improvement of skin hydration and TEWL were examined.
Other: Pyridoxine tri-isopalmitate
2% dosage, oil-in-water emulsion, twice a day, 28 days
It is expected that the long-term application of P-IP increase skin surface water contents and suppress TEWL.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305057
|Cosmos Technical Center|
|Itabashi-ku, Tokyo, Japan, 174-0046|