NCT03469076

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

March 12, 2018

Last Update Submit

March 12, 2018

Conditions

Acne Vulgaris

Keywords

Acne, Comedonal, Mild to Moderate Papulopustular Acne

Outcome Measures

Primary Outcomes (2)

  • Skin microbiome differences

    Analysis of the skin's microbiome at start (baseline) and after treatment with the ACN Cream

    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

    baseline, at 4, 8 and 10 weeks

Study Arms (1)

ACN Cream

EXPERIMENTAL

Patients with mild to moderate acne using ACN Cream

Other: YUN ACN Cream

Interventions

YUN ACN CreamOTHER

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

Also known as: topical cream with live probiotic bacteria
ACN Cream

Eligibility Criteria

Age12 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • mild to moderate acne

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Julien Lambert, Prof. dr

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien Lambert, Prof. dr.

CONTACT

038213223

Ingmar Claes, Dr. Ir.

CONTACT

034430473

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Julien Lambert, MD

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 19, 2018

Study Start

April 25, 2016

Primary Completion

December 14, 2017

Study Completion

March 31, 2018

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

BE(1)