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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

March 12, 2018
March 19, 2018
March 19, 2018
April 25, 2016
December 14, 2017   (Final data collection date for primary outcome measure)
  • 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
  • Clinical acne symptoms [ Time Frame: baseline, at 4, 8 and 10 weeks ]
    Clinical evaluation of acne symptoms
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acne Vulgaris
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
Experimental: ACN Cream
Patients with mild to moderate acne using ACN Cream
Intervention: Other: YUN ACN Cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
March 31, 2018
December 14, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
12 Years to 25 Years   (Child, Adult)
Yes
Contact: Julien Lambert, Prof. dr. 038213223 ext +32
Contact: Ingmar Claes, Dr. Ir. 034430473 ext +32
Belgium
 
 
NCT03469076
16/14/168
B300201628507 ( Other Identifier: Belgian Registration )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Ethisch Comité, UZA, University Hospital, Antwerp
University Hospital, Antwerp
Not Provided
Principal Investigator: Julien Lambert, Prof. dr University Hospital, Antwerp
University Hospital, Antwerp
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP