Atopic Dermatitis
Conditions
Brief summary
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
Detailed 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
Interventions
OTHERTopical L. reeuteri
Tubes with ointment containing L. reuteri DSM17938
Sponsors
BioGaia AB
Innovacion y Desarrollo de Estrategias en Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blinded study. All study staff, including the Principal Investigator and the persons performing the subject assessments, will be blinded during the study. Sealed individual treatment code envelopes will be kept at the clinic to be able to break the code if any emergency occurs, as judged by the Investigator. Tubes with interventions has the same exterior appearence. Emollient are similar in consistency and odour
Intervention model description
Randomized, double blind, placebo controlled trial, 2 parallel arms. Children with mild or moderate atopic dermatitis will be randomly selected at the Pediatric Dermatologic Clinic-Hospital General GEA-Mexico if they fulfill selectioncriteria.
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin appearance modification | 16 weeks | To evaluate the use of a topical emolient containing L. reuteri DSM17938, in terms of its effect on appearance and symptomology in children with mild to moderate atopic dermatitis evaluated by SCORAD test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on Skin microbiota | 12 weeks | To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis. |
| Frequency of adverse events | 16 weeks | To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938 |
| Changes on Quality of life | 16 weeks | To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Children's Dermatology Life Quality Index Score |
| Changes on Family Quality of life: Familys Dermatology Life Quality Index Score | 16 weeks | To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Familys Dermatology Life Quality Index Score. |
| Frecuency of rescue medications | 16 weeks | To evaluate the improvement on AD control after the use of topical L. reuteri DSM17938 by frequency of rescue medications |
Countries
Mexico
Contacts
Primary ContactPedro Gutierrez-Castrellon, MD, PhD
Backup ContactGuadalupe Maldonado-Colin, MSc
Outcome results
None listed