Studying the Skin Microbiome and the Potential of a Topical Probiotic Cream for Patients With Acne
Primary Purpose
Acne Vulgaris
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
YUN ACN Cream
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, Comedonal, Mild to Moderate Papulopustular Acne
Eligibility 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
Sites / Locations
- University Hospital, AntwerpRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ACN Cream
Arm Description
Patients with mild to moderate acne using ACN Cream
Outcomes
Primary Outcome Measures
Skin microbiome differences
Analysis of the skin's microbiome at start (baseline) and after treatment with the ACN Cream
Clinical acne symptoms
Clinical evaluation of acne symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT03469076
First Posted
March 12, 2018
Last Updated
March 12, 2018
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT03469076
Brief Title
Studying the Skin Microbiome and the Potential of a Topical Probiotic Cream for Patients With Acne
Official Title
Studie Van de Huidmicrobiota en Het Potentieel Van Een crème Met Probiotica Bij Personen Met Acne
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
December 14, 2017 (Actual)
Study Completion Date
March 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, Comedonal, Mild to Moderate Papulopustular Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACN Cream
Arm Type
Experimental
Arm Description
Patients with mild to moderate acne using ACN Cream
Intervention Type
Other
Intervention Name(s)
YUN ACN Cream
Other Intervention Name(s)
topical cream with live probiotic bacteria
Intervention Description
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
Primary Outcome Measure Information:
Title
Skin microbiome differences
Description
Analysis of the skin's microbiome at start (baseline) and after treatment with the ACN Cream
Time Frame
baseline; after 4 and 8 weeks of treatment; at 10 weeks, i.e. 2 weeks after stop of treatment
Title
Clinical acne symptoms
Description
Clinical evaluation of acne symptoms
Time Frame
baseline, at 4, 8 and 10 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Lambert, Prof. dr.
Phone
038213223
Ext
+32
First Name & Middle Initial & Last Name or Official Title & Degree
Ingmar Claes, Dr. Ir.
Phone
034430473
Ext
+32
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Lambert, Prof. dr
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Lambert, Prof. Dr
Phone
038213223
Ext
+32
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Studying the Skin Microbiome and the Potential of a Topical Probiotic Cream for Patients With Acne
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