RecruitingPhase 3Phase 4ACTRN12614000008628

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.


Sponsor

Integrated Health Group Pty. Ltd.

Enrollment

80 participants

Start Date

Feb 3, 2014

Study Type

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

Sex: Both males and femalesMin Age: 16 YearssMax Age: 35 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing an oral supplement called Skin Accumax, which contains vitamins A, C, and E, lecithin, and a plant compound called diindolylmethane, to see if it can improve moderate acne. Participants will take the supplement daily for 16 weeks, and researchers will also look at how it affects quality of life and self-esteem. You may be eligible if: - You are between 16 and 35 years of age - You have persistent grade II or III acne (moderate acne) - You are currently only using standard antimicrobial skin washes as your acne treatment - You are otherwise in good health You may NOT be eligible if: - You have recently received acne treatments like corticosteroids, oestrogens, or progesterone (within the past month) - You are female and currently on the contraceptive pill, pregnant, or breastfeeding - You are currently taking blood-thinning medication - You are currently taking part in another clinical trial Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a 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), Ph

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)

QLD, Australia

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ACTRN12614000008628


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