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.
Phase 3
Recruiting
- Conditions
- AcneSkin - Dermatological conditionsAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12614000008628
- Lead Sponsor
- Integrated Health Group Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
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)
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>The reduction in severity of acne will be assessed using photography before, during and at completion of treatment (and results assessed by a dermatologist).[Baseline, 8 weeks and 16 weeks]
- Secondary Outcome Measures
Name Time Method 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.<br>[Baseline, 8 weeks and 16 weeks];Evaluate dietary influences on acne through a 3 day food diary to be filled out at completion of treatment (week 16).<br>[At 16 weeks only<br>]