Studying the Skin Microbiome and the Potential of a Topical Probiotic Cream for Patients With Acne

NCT ID: NCT03469076

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-25
• Study Completion Date: 2018-03-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACN Cream

Patients with mild to moderate acne using ACN Cream

Group Type: EXPERIMENTAL

YUN ACN Cream

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

topical cream with live probiotic bacteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Ethisch Comité, UZA

Prof. Julien Lambert, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julien Lambert, Prof. dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University Hospital, Antwerp

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Julien Lambert, Prof. dr.

Role: CONTACT

038213223 ext. +32

Ingmar Claes, Dr. Ir.

Role: CONTACT

034430473 ext. +32

Facility Contacts

Julien Lambert, Prof. Dr

Role: primary

038213223 ext. +32

Other Identifiers

B300201628507

Identifier Type: OTHER

Identifier Source: secondary_id

16/14/168

Identifier Type: -

Identifier Source: org_study_id