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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03469076
• Other study ID #: 16/14/168
• Secondary ID: B300201628507
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2018
• Last updated: March 12, 2018
• Start date: April 25, 2016
• Est. completion date: March 31, 2018

Study information

• Verified date: March 2018
• Source: University Hospital, Antwerp
• Contact: Julien Lambert, Prof. dr.
• Phone: 038213223
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2018
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• YUN ACN Cream
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

Locations

Country	Name	City	State
Belgium	University Hospital, Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Clinical acne symptoms	Clinical evaluation of acne symptoms	baseline, at 4, 8 and 10 weeks