Alterations in skin hydration, moisture and genomic in patients with dry skin conditions following daily oral palm tocotrienol and squalene (STGAIATM) supplementatio

Not Applicable

• Conditions: Dry skin; xerosis; Skin - Dermatological conditions

• Registration Number: ACTRN12624001057572
• Lead Sponsor: Monash University Malaysia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-30
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Provision of a signed and dated informed consent form
2.Stated willingness to comply with all study procedures and availability to attend study visits for the duration of the study
3.English or Malay-speaking
4.Both sexes who are 25-45- years of age
5.Score of a 10 or higher in the Xerosis Area and Severity Index (XASI).

Exclusion Criteria

1.Current self-reported lactation, pregnancy or active intent to conceive
2.Fever within seven days of study enrolment
3.Self-reported systemic antibiotics (oral or injectable) use in the past six weeks.
4.On treatment or medication
5.Menopause and/or taking hormone replacement therapy
6.Consuming hair, skin and nail supplements or prescribed medicine
7.Have some health-related problem (e,g, flu, fever, allergy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sebum content [Sebumeter baseline, then 28 days, 56 days and 70 days following commencement of treatment];Skin hydration measurement [Corneometer baseline, then 28 days, 56 days and 70 days following commencement of treatment];Trans-epidermal water loss measurement [Tewameter baseline, then 28 days, 56 days and 70 days following commencement of treatment]

Secondary Outcome Measures

Name	Time	Method
The Nutrigenomic Assay included in this study is assessed independently. Blood samples from High dose STGAIA arm at baseline and 2nd visit will be collected. The plasma will be separated from buffy coat, Th cells will be examined for changes in gene expression between control and interventions.[Gene Microarray baseline and then Day 56 following commencement of treatment];Quantification of tocotrienol and squalene levels in sebum [using LCMS technique baseline, then 28 days, 56 days and 70 days following commencement of treatment];Quantification of tocotrienol and squalene levels in plasma[LC-MS/MS technique baseline, then 28 days, 56 days and 70 days following commencement of treatment]