Topical L. Reuteri in Children With Atopic Dermatitis (ADreuteri)

Innovation and Development of Health Strategies

Status: Unknown

Conditions: Atopic Dermatitis

Treatments: Other: Topical L. reeuteri

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04265716

CSUB0174

Details and patient eligibility

About

This study evaluates the safety and efficacy of the probiotic L. reuteri vs control product as an adjuvant for improving the skin appearance of children with mild or moderate atopic dermatitis. All children will receive the standard of care. Half of the children will receive topical L. reuteri in emollient, while the other half will receive the standard of care plus control product

Full description

AD if a very frequent allergic skin disorders in children. Produce a negative significant impact on quality of life and related costs. Recently the changes of skin microbiota had been related with inadequate evolution of atopic dermatitis.

L. reuteri had been identified with some effect to reduce skin inflammation and help to modulate inflammatory pathways on skin. Investigators expect using topical L. reuteri as adjuvant some improvement on skin appearance due to the mode of action previous referenced additionally to some potential changes on microbiome

Enrollment: 102 estimated patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children age 1 to 8 years old
• Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
• SCORAD Index 15 to 50, inclusive
• Subjects whose parents or legal representative are willing to sign the informed consent
• When the child is 8, he/she must also give consent to participate in the study

Exclusion criteria

• Use of phototherapy for atopic dermatitis
• Systemic or topic corticosteroids in tthe 30 days prior to the study
• Immunosuppressive or cytostatic drugs in the 2 months prior to the study
• Use of probiotics in the 2 weeks prior to the study
• Other allergic severe disease (asthma, allergic rhinitis)
• Systemic antibiotics in the four days prior to the study
• Fever (temperature> 37.5 °C axillary or equivalent)
• Pathologies associated with immunodeficiency or cancer processes
• Dermatological diseases that may hinder the evaluation of atopic dermatitis or require the continued use of topical corticosteroids
• Subjects for whom any of the studies products are contraindicated according to their technical specifications
• Subjects who have participated in research studies with any products in the 3 months prior to the trial

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

L. reuteri

Active Comparator group

Description:

Topical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day

Treatment:

Other: Topical L. reeuteri

Placebo

Placebo Comparator group

Description:

Rubbed into skin twice per day

Treatment:

Other: Topical L. reeuteri