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

NCT04771910 | Unknown DMC

• 1 other identifier: B3002020000099
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Skin microbiome; Probiotics; Lactobacillus spp.

Outcome Measures

Primary Outcomes (3)

• Change from baseline in skin microbiome composition

  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

  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

  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).

Study Arms (2)

Topical cream with live probiotic bacteria (YUN)

EXPERIMENTAL

Patients with atopic dermatitis using topical cream with live probiotic bacteria

Other: Topical cream with live probiotic bacteria

Placebo cream (YUN)

PLACEBO COMPARATOR

Patients with atopic dermatitis using placebo cream (same formulation as probiotic cream except live probiotic bacteria)

Other: Placebo cream

Interventions

Topical cream with live probiotic bacteria OTHER

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).

Also known as: ACN cream (YUN)

Topical cream with live probiotic bacteria (YUN)

Placebo cream OTHER

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).

Placebo cream (YUN)

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with atopic dermatitis and healthy volunteers

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• YUN NV: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sarah Lebeer, Prof

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

• Margo Hagendorens, Prof

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Lebeer, Prof

CONTACT

+3232653285; sarah.lebeer@uantwerpen.be

Lize Delanghe, Msc

CONTACT

+3232653240; lize.delanghe@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Sarah Lebeer

Model Details: All AD patients will receive both treatments (verum and placebo). Verum cream will be applied on one side of the body (elbow or knee cavities), the placebo cream on the other side.

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: February 25, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)