Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000848202
Ethics application status
Approved
Date submitted
30/09/2009
Date registered
30/09/2009
Date last updated
7/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical study in healthy volunteers to determine whether orally consumed tocopheryl phosphates are incorporated into oil produced/secreted by the skin.
Scientific title
A clinical study in healthy volunteers to determine whether orally consumed tocopheryl phosphates are incorporated into secreted sebum
Secondary ID [1] 251737 0
POH022-09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tocopheryl phosphates and secreted sebum. 251941 0
Condition category
Condition code
Skin 252126 252126 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mixed tocopheryl phosphates (TPM) capsules at approx. 400 International Units (IU) (~316 mg) to be taken once a day (after breakfast, between 7 am and 9 am), for 28 days.
Intervention code [1] 241360 0
Treatment: Drugs
Comparator / control treatment
Alpha-tocopheryl acetate capsules at approx. 400 IU (~316 mg) to be taken once a day (after breakfast, between 7 am and 9 am), for 28 days.
Control group
Active

Outcomes
Primary outcome [1] 253005 0
To determine if orally consumed mixed tocopheryl phosphates increase plasma, skin and sebum tocopheryl phosphate and di-tocopheryl phosphate concentrations.
Timepoint [1] 253005 0
Blood samples for plasma PK analysis will be collected on Days 0 (baseline), 1, 3, 7, 14, 21 and 28.

Sebum samples will be collected from the forehead (by use of Sebutape strip) on Days 0 (baseline), 1, 3, 7, 14, 21 and 28.

Skin samples will be collected by tape stripping (Food & Drug Administration (FDA) approved) of the volar forearm on Days 0 (baseline), 1, 3, 7, 14, 21 and 28, and from the forehead on Day 28.
Secondary outcome [1] 257777 0
To determine if mixed tocopheryl phosphate tablets increase alpha-tocopherol content in the plasma, skin and sebum.
Timepoint [1] 257777 0
Blood samples for plasma PK analysis will be collected on Days 0 (baseline), 1, 3, 7, 14, 21 and 28.

Sebum samples will be collected from the forehead (by use of Sebutape strip) on Days 0 (baseline), 1, 3, 7, 14, 21 and 28.

Skin samples will be collected by tape stripping (FDA approved) of the volar forearm on Days 0 (baseline), 1, 3, 7, 14, 21 and 28, and from the forehead on Day 28.

Eligibility
Key inclusion criteria
- Provision of written informed consent.
- "Healthy" male or female.
- At least 18 years old.
- Fitzpatrick skin types II or III.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant or breastfeeding.
- History of dermatological disorders.
- Current medical problems or systemic medication.
- Oral or topical anti-oxidant supplementation within 14 days of baseline.
- Smokers.
- Exposure to intense solar or artificial UV/ tanning salons in the 3 months prior to baseline.
- Unable or unwilling to use Vitamin E free skin care products for the duration of the trial.
- Taking warfarin or blood thinning medications.
- Dependent on iron supplements.
- Diabetes, hyperthyroidism, or heart disease.
- Unwilling or unable to avoid ultraviolet (UV) exposure for the duration of the trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be randomly allocated to a study treatment (using a manual block system of allocation to treatments).

The study is open label so all participants will be aware of which arm they are on.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
26/10/2010
Date of last participant enrolment
Anticipated
Actual
3/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243819 0
Commercial sector/Industry
Name [1] 243819 0
Phosphagenics Limited
Country [1] 243819 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 237169 0
None
Name [1] 237169 0
Address [1] 237169 0
Country [1] 237169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243949 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 243949 0
246 Clayton Road
Clayton, Victoria 3168
Ethics committee country [1] 243949 0
Australia
Date submitted for ethics approval [1] 243949 0
11/09/2009
Approval date [1] 243949 0
30/09/2009
Ethics approval number [1] 243949 0

Summary
Brief summary
Alpha-tocopherol plays an important role in preserving skin barrier function; it is concentrated in sebum and secreted to the skin in high concentrations. It is not known whether supplemented tocopheryl phosphates, which have been shown to play a protective role in prevention of UV damage, follow a similar metabolic pathway to the skin surface as alpha-tocopherol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30329 0
Dr Roksan Libinaki
Address 30329 0
Phosphagenics Ltd
11 Duerdin St
Clayton, 3168
VICTORIA
Country 30329 0
Australia
Phone 30329 0
+61 3 9565 1119
Fax 30329 0
Email 30329 0
[email protected]
Contact person for public queries
Name 13576 0
Miss Yelda Ogru
Address 13576 0
Phosphagenics Ltd
11 Duerdin St
Clayton, 3168
VICTORIA
Country 13576 0
Australia
Phone 13576 0
+61 3 9565 1156
Fax 13576 0
+61 3 9565 1151
Email 13576 0
[email protected]
Contact person for scientific queries
Name 4504 0
Miss Yelda Ogru
Address 4504 0
Phosphagenics Ltd
11 Duerdin St
Clayton, 3168
VICTORIA
Country 4504 0
Australia
Phone 4504 0
+61 3 9565 1156
Fax 4504 0
+61 3 9565 1151
Email 4504 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.