Studying the Skin Microbiome and the Potential of a Topical Probiotic Cream for Patients With Acne

Study Overview
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Brief Summary
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In this study the topical use of cream with live probiotic bacteria was evaluated for its efficacy in reducing acne symptoms and its effect on the skin microbiota on patients with acne. Patients with mild to moderate acne used the probiotic cream for 8 weeks and clinical evaluation and sampling was done at start, 4, 8 and 10 weeks. Next-Generation Sequencing was used to analyze the skin microbiota of the patients.

Detailed Description
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Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects have been extensively studied in the gastrointestinal niche but it becomes more and more clear that other niches are also interesting for the potential of probiotics. Recent breakthroughs in 'next generation sequencing' (NGS) technologies are making it now possible to map the microbiota after DNA extraction, which is very interesting for bacteria that are not or difficult to cultivate. The research into the microbiota of the skin with such new NGS technologies currently limited, but shows that there is also an equilibrium in the skin composition of the microbiota and that there is a disturbance of the skin microbiota in acne (Murillo & Raoult, 2013). In acne vulgaris it is known that the condition is multifactorial and that both hormonal triggers and environmental factors play a role. However, it is also known that Propionibacterium acnes play an important role in the inflammation of the sebaceous gland follicles. Probiotic strains with antipathogenic activity against this bacterium and suitable for application to the skin is thus potentially able to restore the balance of the skin microbiota and reduce acne symptoms.

Official Title
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Studie Van de Huidmicrobiota en Het Potentieel Van Een crème Met Probiotica Bij Personen Met Acne

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: YUN ACN Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild to moderate acne Exclusion Criteria: local treatments, including cleansers, soaps, antimycotics and antibiotics within 2 weeks prior to start of study use of oral antibiotics within 4 weeks prior to start of study use of systemic retinoids within 6 months prior to start of study

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACN Cream<br>Patients with mild to moderate acne using ACN Cream | Other: YUN ACN Cream<br>* YUN ACN Cream with live probiotic bacteria (min. 10-6 à 10-7 CFU per application) applied twice daily (morning and evening) on the entire face<br>* Other names: topical cream with live probiotic bacteria;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin microbiome differences | Analysis of the skin's microbiome at start (baseline) and after treatment with the ACN Cream | baseline; after 4 and 8 weeks of treatment; at 10 weeks, i.e. 2 weeks after stop of treatment | 
| Clinical acne symptoms | Clinical evaluation of acne symptoms | baseline, at 4, 8 and 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Comedonal, Mild to Moderate Papulopustular Acne