CompletedPhase 2ACTRN12607000140459

Phase 2, 'Proof of Principle', Placebo Controlled, Randomised, Parallel Group Pilot Study of the Effect of a New Combined Acne Treatment in Patients with Mild to Moderate Acne.

Pilot study in patients with mild to moderate acne utilising a facial cleanser, topical gel and oral supplement compared to placebo for treatment of acne.


Sponsor

LifeSource Group Holdings Pty Ltd

Enrollment

20 participants

Start Date

Mar 1, 2007

Study Type

Interventional

Conditions

Summary

This is a pilot study to test in a small number of patients a holistic approach to acne treatment utilising a facial cleanser and topical gel treatment combined with an oral supplement combining natural ingredients which should not cause local irritation or lead to resistant organisms. The unique combination of natural ingredients aims to both cleanse the skin and target internal factors that will assist to promote healthy skin and to help alleviate acne. The Sponsor is looking to develop a suitable natural alternative to currently available pharmaceutical products for the treatment of mild to moderate acne.


Eligibility

Sex: Both males and femalesMin Age: 15 YearssMax Age: 35 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests a new combined acne treatment in people aged 15 to 35 with mild to moderate inflammatory acne. Participants are randomly assigned to the new treatment or a placebo to see if the combination product reduces acne. People who have used oral retinoids (like Accutane) in the past 2 years or systemic acne therapies in the past 4 weeks are not eligible.

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

Three products will be used twice daily in the trial.

Three products will be used twice daily in the trial. A topical gel containing nicotinamide (4% w/w) and sandalwood oil (2% w/w) as the actives, a cosmetic facial cleanser and an oral supplement containing a combination of vitamins and minerals (Zinc 12.5mg, Nicotinamide 25mg, Vitamin B6 25mg Vitamin E 25IU, Vitamin C 125mg, Linseed oil 250mg and Vitamin A 1250IU). Products will be used twice daily i.e. Face will be cleansed with facial cleanser, topical gel will be applied to affected area and 1x capsule will be taken. This process is repeated twice daily i.e. morning and night. These products will be compared against matching placebos i.e. identical formulations as the treatment minus the actives. There will be 2 treatment groups- active and placebo. Active group will take Active topical gel, Active facial cleanser and Active oral supplement.


Locations(1)

Australia

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ACTRN12607000140459