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.

Conditions

None listed

Brief 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.

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

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, V

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

15 Years to 35 Years

Healthy volunteers

No

Inclusion criteria

Subjects with mild to moderate inflammatory acne; of any racial/ethnic group.

Exclusion criteria

Oral retinoid use within 2 years of entry into the study; Systemic acne therapies within 4 weeks of entry into the study; Subjects with predominantly comedonal acne; Subjects with predominant retention acne.

Outcome results