Study of the Skin Microbiome and the Potential of a Topical Probiotic Cream for Atopic Dermatitis

April 27, 2021 updated by: ethisch.comite@uza.be, University Hospital, Antwerp
The skin microbiome of atopic dermatitis patients and healthy volunteers will be studies by collecting and analysing skin swabs on different timepoint. Additional, effort will be made to isolate and characterize Lactobacillus spp. and other beneficial micro-organisms on the skin. Second aim of this study is to evaluate a topical probiotic cream in atopic dermatitis treatment. A double-blind placebo-controlled intervention study will be performed in parallel with the skin microbiome analysis. Both clinical effect on the symptoms of atopic dermatitis and effect on the skin microbiome and survival of beneficial bacteria on the skin will be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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 atopic dermatitis (AD). The etiology of AD is complex, with the manifestation of the disease being influenced by various genetic and immune mechanisms acting in concert with environmental factors. A reduction in the skin microbial diversity is often observed and flares are characterized by an abundance of skin pathobionts such as Staphylococcus aureus. Therefore, topical probiotic strains could have a positive effect on the skin microbiome and function by inhibiting pathogens, restoring the skin microbiome and/or barrier function and executing anti-inflammatory effects on the skin cells. The main objectives of this study are to analyse the skin microbiome in healthy volunteers and patients AD to obtain in depth data of the composition of the skin microbiome and identify possible biomarkers for AD. In parallel, a double-blind placebo-controlled study with topically applied live lactobacilli will be performed to give more insights in the working mechanisms of lactobacilli on AD skin. More specifically to evaluate the effect of the 'live' Lactobacillus species as 'active ingredient' in relation to acne symptoms and skin microbiome modulation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with atopic dermatitis and healthy volunteers

Exclusion Criteria AD patients:

  • no use of topical antibiotics and/or corticosteroids within 2 weeks before the start
  • no use of oral antibiotics within 1 month before the start
  • no immunodeficiency disease

Exclusion Criteria Healthy Population:

  • no use of topical antibiotics and/or corticosteroids within 2 weeks before the start
  • no use of oral antibiotics within 1 month before the start
  • no immunodeficiency disease
  • no history of atopic dermatitis or other inflammatory skin disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Topical cream with live probiotic bacteria (YUN)
Patients with atopic dermatitis using topical cream with live probiotic bacteria
Other: Topical cream with live probiotic bacteria
Application of the probiotic cream once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as placebo cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w).
Other Names:
  • ACN cream (YUN)
Placebo Comparator: Placebo cream (YUN)
Patients with atopic dermatitis using placebo cream (same formulation as probiotic cream except live probiotic bacteria)
Other: Placebo cream
Application of the placebo cream (same formulation as probiotic cream except live probiotic bacteria) once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as probiotic cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in skin microbiome composition
Time Frame: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: skin swab at baseline and after 12 weeks (no product use)..
Extraction of microbial DNA out of skin swabs. Analysis of differences in bacterial communities colonizing the skin between healthy individuals and AD patients measured via Next Generation Sequencing techniques and qPCR assays.
AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: skin swab at baseline and after 12 weeks (no product use)..
Change from baseline in AD severity scoring based on Eczema Area and Severity Index
Time Frame: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: NA
Evaluation of atopic dermatitis symptoms via a scoring system based on Eczema Area and Severity Index (EASI). The EASI will be adjusted to the limited area of elbow or knee cavities.
AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: NA
Change from baseline in itching via Visual Analogue Scale
Time Frame: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks).
The effect of the treatment of itching of the skin caused by atopic dermatitis lesions will be evaluated using Visual Analogue Scale (VAS).
AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Antwerp

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
YUN NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah Lebeer, Prof, Universiteit Antwerpen
  • Principal Investigator: Margo Hagendorens, Prof, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B3002020000099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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