Acne VulgarisNCT03469076
Studying the Skin Microbiome and the Potential of a Topical Probiotic Cream for Patients With Acne
A study testing YUN ACN Cream in people with Acne Vulgaris, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- YUN ACN Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Apr 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- mild to moderate acne
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Julien Lambert, Prof. dr. contact
Ingmar Claes, Dr. Ir. contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospital, Antwerp
Edegem, Antwerp, 2650
Julien Lambert, Prof. Dr, 038213223 ext. +32
About this study
Official title: 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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- YUN ACN Cream
- Keywords
- Acne, Comedonal, Mild to Moderate Papulopustular Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YUN ACN CreamOther
Also called topical cream with live probiotic bacteria
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
| Study group | Role | What they receive |
|---|---|---|
| ACN Cream | Experimental | Patients with mild to moderate acne using ACN Cream Receives: Other: YUN ACN Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin microbiome differences
Analysis of the skin's microbiome at start (baseline) and after treatment with the ACN Cream
Measured: 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
Measured: baseline, at 4, 8 and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start25 Apr 2016
- Primary completion14 Dec 2017
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité, UZA, University Hospital, Antwerp
- Investigators
- Julien Lambert, Prof. dr, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469076
- Sponsor's protocol ID
- 16/14/168
- Other IDs
- B300201628507
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studie Van de Huidmicrobiota en Het Potentieel Van Een crème Met Probiotica Bij Personen Met Acne
- ClinicalTrials.gov ID
- NCT03469076
- Acronym / sponsor ID
- 16/14/168
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Comedonal, Mild to Moderate Papulopustular Acne
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACN Cream | Experimental | Other: YUN ACN CreamPatients with mild to moderate acne using ACN Cream |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- mild to moderate acne
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YUN ACN CreamAlso: topical cream with live probiotic bacteriaYUN 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 | ACN Cream |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Lambert, Prof. dr. contact
Ingmar Claes, Dr. Ir. contact
Julien Lambert, Prof. dr principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YUN ACN Cream in people with Acne Vulgaris, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Lambert, Prof. dr. (038213223 ext. +32), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.