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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: YUN ACN Cream

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • University Hospital, Antwerp
      • Contact: Julien Lambert, Prof. Dr; Phone Number: +32 038213223

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ACN Cream; Patients with mild to moderate acne using ACN Cream	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; Other Names: topical cream with live probiotic bacteria

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Julien Lambert, Prof. dr, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2016
• Primary Completion (ACTUAL): December 14, 2017
• Study Completion (ANTICIPATED): March 31, 2018

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (ACTUAL): March 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Acne, Comedonal, Mild to Moderate Papulopustular Acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 16/14/168; B300201628507 (OTHER: Belgian Registration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No