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

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ClinicalTrials.gov Identifier: NCT03469076
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité, UZA, University Hospital, Antwerp

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Other: YUN ACN Cream Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Studie Van de Huidmicrobiota en Het Potentieel Van Een crème Met Probiotica Bij Personen Met Acne
Actual Study Start Date : April 25, 2016
Actual Primary Completion Date : December 14, 2017
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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 Name: topical cream with live probiotic bacteria




Primary Outcome Measures :
  1. Skin microbiome differences [ Time Frame: baseline; after 4 and 8 weeks of treatment; at 10 weeks, i.e. 2 weeks after stop of treatment ]
    Analysis of the skin's microbiome at start (baseline) and after treatment with the ACN Cream

  2. Clinical acne symptoms [ Time Frame: baseline, at 4, 8 and 10 weeks ]
    Clinical evaluation of acne symptoms



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469076


Contacts
Contact: Julien Lambert, Prof. dr. 038213223 ext +32
Contact: Ingmar Claes, Dr. Ir. 034430473 ext +32

Locations
Belgium
University Hospital, Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Julien Lambert, Prof. Dr    038213223 ext +32      
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Julien Lambert, Prof. dr University Hospital, Antwerp

Responsible Party: Ethisch Comité, UZA, Prof. Julien Lambert, MD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03469076     History of Changes
Other Study ID Numbers: 16/14/168
B300201628507 ( Other Identifier: Belgian Registration )
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ethisch Comité, UZA, University Hospital, Antwerp:
Acne, Comedonal, Mild to Moderate Papulopustular Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases