Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
312081
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Dry skin
333706
0
Query!
xerosis
333707
0
Query!
Condition category
Condition code
Skin
330387
330387
0
0
Query!
Dermatological conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
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,
Query!
Intervention code [1]
328521
0
Treatment: Other
Query!
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.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
338150
0
Sebum content
Query!
Assessment method [1]
338150
0
Sebumeter
Query!
Timepoint [1]
338150
0
baseline, then 28 days, 56 days and 70 days following commencement of treatment
Query!
Primary outcome [2]
338151
0
Skin hydration measurement
Query!
Assessment method [2]
338151
0
Corneometer
Query!
Timepoint [2]
338151
0
baseline, then 28 days, 56 days and 70 days following commencement of treatment
Query!
Primary outcome [3]
338152
0
Trans-epidermal water loss measurement
Query!
Assessment method [3]
338152
0
Tewameter
Query!
Timepoint [3]
338152
0
baseline, then 28 days, 56 days and 70 days following commencement of treatment
Query!
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.
Query!
Assessment method [1]
434711
0
Gene Microarray
Query!
Timepoint [1]
434711
0
baseline and then Day 56 following commencement of treatment
Query!
Secondary outcome [2]
435934
0
Quantification of tocotrienol and squalene levels in sebum
Query!
Assessment method [2]
435934
0
using LCMS technique
Query!
Timepoint [2]
435934
0
baseline, then 28 days, 56 days and 70 days following commencement of treatment
Query!
Secondary outcome [3]
435936
0
Quantification of tocotrienol and squalene levels in plasma
Query!
Assessment method [3]
435936
0
LC-MS/MS technique
Query!
Timepoint [3]
435936
0
baseline, then 28 days, 56 days and 70 days following commencement of treatment
Query!
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).
Query!
Minimum age
25
Years
Query!
Query!
Maximum age
45
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by providing the supplement in a sealed opaque envelopes.
Query!
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)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
ANOVA
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
4/11/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
30/06/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
29/08/2025
Query!
Actual
Query!
Sample size
Target
36
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
26291
0
Malaysia
Query!
State/province [1]
26291
0
Selangor
Query!
Funding & Sponsors
Funding source category [1]
316440
0
Commercial sector/Industry
Query!
Name [1]
316440
0
Phytogaia (M) Sdn Bhd.
Query!
Address [1]
316440
0
Query!
Country [1]
316440
0
Malaysia
Query!
Primary sponsor type
University
Query!
Name
Monash University Malaysia
Query!
Address
Query!
Country
Malaysia
Query!
Secondary sponsor category [1]
318858
0
Hospital
Query!
Name [1]
318858
0
Hospital Universiti kebangsaan Malaysia
Query!
Address [1]
318858
0
Query!
Country [1]
318858
0
Malaysia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315232
0
Monash University Human Research Ethics Committee
Query!
Ethics committee address [1]
315232
0
Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor Darul Ehsan, Monash University Malaysia.
Query!
Ethics committee country [1]
315232
0
Malaysia
Query!
Date submitted for ethics approval [1]
315232
0
01/06/2023
Query!
Approval date [1]
315232
0
15/09/2023
Query!
Ethics approval number [1]
315232
0
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
134070
0
Dr Kasthuri bai Magalingam
Query!
Address
134070
0
Monash University Malaysia Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia
Query!
Country
134070
0
Malaysia
Query!
Phone
134070
0
+60355146319
Query!
Fax
134070
0
Query!
Email
134070
0
[email protected]
Query!
Contact person for public queries
Name
134071
0
Kasthuri bai Magalingam
Query!
Address
134071
0
Monash University Malaysia Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia
Query!
Country
134071
0
Malaysia
Query!
Phone
134071
0
+60355146319
Query!
Fax
134071
0
Query!
Email
134071
0
[email protected]
Query!
Contact person for scientific queries
Name
134072
0
Kasthuri bai Magalingam
Query!
Address
134072
0
Monash University Malaysia Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia
Query!
Country
134072
0
Malaysia
Query!
Phone
134072
0
+60355146319
Query!
Fax
134072
0
Query!
Email
134072
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
22323
Study protocol
387753-(Uploaded-03-05-2024-16-13-25)-Study-related document.pdf
22325
Informed consent form
387753-(Uploaded-03-05-2024-16-07-59)-Study-related document.docx
22326
Ethical 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.
Download to PDF