Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000008628
Ethics application status
Approved
Date submitted
10/12/2013
Date registered
3/01/2014
Date last updated
25/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, randomised, placebo-controlled study to evaluate the effectiveness of an orally dosed supplement, Skin Accumax, containing vitamin A, vitamin E, vitamin C, phosphatidylcholine (lecithin) and diindolylmethane, on treating acne in men and women aged between 16 and 35.
Scientific title
A double-blind, randomised, placebo-controlled study to evaluate the effectiveness of an orally dosed supplement, Skin Accumax, containing vitamin A, vitamin E, vitamin C, phosphatidylcholine (lecithin) and diindolylmethane, on treating acne in men and women aged between 16 and 35.
Secondary ID [1] 283467 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne 290381 0
Condition category
Condition code
Skin 290772 290772 0 0
Dermatological conditions
Alternative and Complementary Medicine 291124 291124 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an orally dose nutritional supplement called Skin Accumax. The active ingredients in the supplement are Vitamin A (200ug), Vitamin E (19.6mg alpha tocopherol), Vitamin C (40mg), Phosphatidylcholine (75mg) and Diindolylmethane (18mg).

The daily dose will be 4 capsules per day; 2 capsules with breakfast and 2 capsules with the evening meal.

The duration of treatment is 16 weeks.

Strategies used to monitor adherence include monitoring through fortnightly follow-up, email contact, return of used medication at completion of study.
Intervention code [1] 288176 0
Treatment: Other
Comparator / control treatment
Capsules containing maltodextrin identical in size and shape of the active.
Control group
Placebo

Outcomes
Primary outcome [1] 290771 0
Assess the effectiveness of the orally dosed nutritional supplement, Skin Accumax, on treatment of persistent acne grade II and III in men and women aged 16-35 over 16 weeks.

The reduction in severity of acne will be assessed using photography before, during and at completion of treatment (and results assessed by a dermatologist).
Timepoint [1] 290771 0
Baseline, 8 weeks and 16 weeks
Secondary outcome [1] 305247 0
Assess quality of life and self-esteem before (baseline) and after treatment with Skin Accumax using a QOL questionnaire, administered before, during and at completion of treatment.
Timepoint [1] 305247 0
Baseline, 8 weeks and 16 weeks
Secondary outcome [2] 306014 0
Evaluate dietary influences on acne through a 3 day food diary to be filled out at completion of treatment (week 16).
Timepoint [2] 306014 0
At 16 weeks only

Eligibility
Key inclusion criteria
Males and females
Aged between 16 and 35
Have persistent acne grade II and III
Currently using standard anti-microbial washes as the skin treatment only
Otherwise healthy
Written informed consent from the subject and/or guardians (under 18 years)
Minimum age
16 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
Males or females receiving treatment for acne (including corticosteroids, estrogens, progesterone) within the last month
Females currently on the contraceptive pill, pregnant or breastfeeding
Any person currently on anti-coagulant therapy.
Participation in any other clinical trial during last 30 days
Simultaneous participation in another clinical trial

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)
The potential participants are screened by the medical monitor for inclusion in the study.
The eligible participants are enrolled by Investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the numbered containers labelled prior to delivery to Investigation Site.
Product allocated as participants are enrolled in sequential order (1-80).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size required to assess a 30% reduction on acne severity, based on an 80% confidence, is 30 participants in each arm, total of 60 participants.

The primary endpoint is reduction in Acne Severity (assessed at baseline, week 8 and week 16). The severity is defined as the severity of acne and the percentage of the face and neck affected. The mean percentage change in area will be calculated. Data will be analysed using SPSS statistical software to test for equality of means between the active and placebo groups at each time point.

QOL questionnaires will be analysed using SPSS statistical software for difference in mean values between the active and placebo group at each time point. The specific statistical test will be determined once the initial data has been analysed for normality.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7499 0
4005 - New Farm

Funding & Sponsors
Funding source category [1] 288173 0
Commercial sector/Industry
Name [1] 288173 0
International Institute for Anti-aging (IIAA)
Country [1] 288173 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Integrated Health Group Pty. Ltd.
Address
Integrated Health Group Pty. Ltd.
362 Water Street Fortitude Valley
Brisbane QLD 4002
Country
Australia
Secondary sponsor category [1] 286897 0
None
Name [1] 286897 0
Address [1] 286897 0
Country [1] 286897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290086 0
Queensland Clinical Trial Network
Ethics committee address [1] 290086 0
Level 3, 88 Jephson Street
Toowong, QLD, 4066
Ethics committee country [1] 290086 0
Australia
Date submitted for ethics approval [1] 290086 0
Approval date [1] 290086 0
18/11/2013
Ethics approval number [1] 290086 0

Summary
Brief summary
This is a single-site, double-blind, randomised, clinical trial of 16 weeks duration and utilising active and placebo arms with baseline data collection.

The study aims to:
Assess the effectiveness of orally dosed supplement Skin Accumax on treatment of persistent acne grade II and lll in men and women aged 16 to 35, over 16 weeks.
Assess quality of life and self-esteem before and after treatment.
Evaluate dietary influences on acne through dietary survey.
Evaluate safety and tolerability over 16 weeks.
Provide information that will be required by Therapeutic Goods Administration (TGA) and international regulatory bodies to support product tolerability and therapeutic claims.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43894 0
Dr Elizabeth Steels
Address 43894 0
Integrated Health Group Pty. Ltd. 362 Water Street Fortitude Valley Brisbane
4002 QLD
Country 43894 0
Australia
Phone 43894 0
+61 7 31620909
Fax 43894 0
Email 43894 0
[email protected]
Contact person for public queries
Name 43895 0
Dr Elizabeth Steels
Address 43895 0
Integrated Health Group Pty. Ltd. P.O. Box 68 New Farm Brisbane 4005 QLD
Country 43895 0
Australia
Phone 43895 0
+61 7 31620909
Fax 43895 0
Email 43895 0
[email protected]
Contact person for scientific queries
Name 43896 0
Dr Elizabeth Steels
Address 43896 0
Integrated Health Group Pty. Ltd. P.O. Box 68 New Farm Brisbane 4005 QLD
Country 43896 0
Australia
Phone 43896 0
+61 7 31620909
Fax 43896 0
Email 43896 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.