Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001057572
Ethics application status
Approved
Date submitted
3/05/2024
Date registered
30/08/2024
Date last updated
30/08/2024
Date data sharing statement initially provided
30/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Alterations in skin hydration, moisture and genomic in patients with dry skin conditions following daily oral palm tocotrienol and squalene (STGAIATM) supplementation
Scientific title
Alterations in skin hydration, moisture and genomic in adult patients with dry skin conditions following daily oral palm tocotrienol and squalene (STGAIATM) supplementation
Secondary ID [1] 312081 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry skin 333706 0
xerosis 333707 0
Condition category
Condition code
Skin 330387 330387 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 2 types of interventions in this study: Low Dose STGAIA and High dose STGAIA.
The supplement is administered as a single oral sachet containing Tocogaia (330 mg) and squalene (50 mg) for low dose STGAIA group and Tocogaia (330mg), squalene (50mg) twice a day for high dose STGAIA, This supplement is administered by mixing the contents of the sachet with water and taking it after a meal. Any unused sachets must be returned for proper disposal or evaluation. Patients will undergo skin, hair, and nail assessments at the baseline, first visit, second visit, and third visit. For the nutrigenomic study, samples from the baseline and second visit of the High Dose STGAIA group will be utilized.




Low Dose STGAIA
a.(Tocogaia:330mg, squalene:50mg),
b. single administration,
c. oral sachet,
d. once a day,
e. administered and monitored under the supervision of a dermatologist,
f. supplement sachet return,

High Dose STGAIA
a.(Tocogaia:660mg, squalene:100mg),
b. double administration,
c. oral sachet,
d. twice a day,
e. administered and monitored under the supervision of a dermatologist,
f. supplement sachet return,
Intervention code [1] 328521 0
Treatment: Other
Comparator / control treatment
Control group
The placebo will be packaged to resemble the intervention. It will consist of a glucose sachet and should be taken once a day during the study duration.
Control group
Placebo

Outcomes
Primary outcome [1] 338150 0
Sebum content
Timepoint [1] 338150 0
baseline, then 28 days, 56 days and 70 days following commencement of treatment
Primary outcome [2] 338151 0
Skin hydration measurement
Timepoint [2] 338151 0
baseline, then 28 days, 56 days and 70 days following commencement of treatment
Primary outcome [3] 338152 0
Trans-epidermal water loss measurement
Timepoint [3] 338152 0
baseline, then 28 days, 56 days and 70 days following commencement of treatment
Secondary outcome [1] 434711 0
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.
Timepoint [1] 434711 0
baseline and then Day 56 following commencement of treatment
Secondary outcome [2] 435934 0
Quantification of tocotrienol and squalene levels in sebum
Timepoint [2] 435934 0
baseline, then 28 days, 56 days and 70 days following commencement of treatment
Secondary outcome [3] 435936 0
Quantification of tocotrienol and squalene levels in plasma
Timepoint [3] 435936 0
baseline, then 28 days, 56 days and 70 days following commencement of treatment

Eligibility
Key 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).
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by providing the supplement in a sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 26291 0
Malaysia
State/province [1] 26291 0
Selangor

Funding & Sponsors
Funding source category [1] 316440 0
Commercial sector/Industry
Name [1] 316440 0
Phytogaia (M) Sdn Bhd.
Country [1] 316440 0
Malaysia
Primary sponsor type
University
Name
Monash University Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 318858 0
Hospital
Name [1] 318858 0
Hospital Universiti kebangsaan Malaysia
Address [1] 318858 0
Country [1] 318858 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315232 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315232 0
Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor Darul Ehsan, Monash University Malaysia.
Ethics committee country [1] 315232 0
Malaysia
Date submitted for ethics approval [1] 315232 0
01/06/2023
Approval date [1] 315232 0
15/09/2023
Ethics approval number [1] 315232 0

Summary
Brief summary
This clinical trial aims to investigate the protective effects of tocotrienols and squalene on the skin of patients with dry skin conditions. Tocotrienols, a subgroup of vitamin E known for their strong antioxidant properties, and squalene, a colorless oil abundant in skin sebum, Alteration in tocotrienol and squalene levels in skin may contribute to dry skin conditions, and our hypothesis is that supplementing these nutrients could potentially alleviate this issue.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134070 0
Dr Kasthuri bai Magalingam
Address 134070 0
Monash University Malaysia Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia
Country 134070 0
Malaysia
Phone 134070 0
+60355146319
Fax 134070 0
Email 134070 0
[email protected]
Contact person for public queries
Name 134071 0
Kasthuri bai Magalingam
Address 134071 0
Monash University Malaysia Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia
Country 134071 0
Malaysia
Phone 134071 0
+60355146319
Fax 134071 0
Email 134071 0
[email protected]
Contact person for scientific queries
Name 134072 0
Kasthuri bai Magalingam
Address 134072 0
Monash University Malaysia Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia
Country 134072 0
Malaysia
Phone 134072 0
+60355146319
Fax 134072 0
Email 134072 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22323Study protocol    387753-(Uploaded-03-05-2024-16-13-25)-Study-related document.pdf
22325Informed consent form    387753-(Uploaded-03-05-2024-16-07-59)-Study-related document.docx
22326Ethical approval    387753-(Uploaded-03-05-2024-16-08-31)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.