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.
Integrated Health Group Pty. Ltd.
80 participants
Feb 3, 2014
Interventional
Conditions
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.
Eligibility
Inclusion Criteria6
- 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)
Exclusion Criteria6
- 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
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Interventions
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.
Locations(1)
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ACTRN12614000008628