Topical L. Reuteri in Children With Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Other: Topical L. reeuteri
- Registration Number
- NCT04265716
- Lead Sponsor
- Innovacion y Desarrollo de Estrategias en Salud
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 102
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L. reuteri Topical L. reeuteri Topical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day Placebo Topical L. reeuteri Rubbed into skin twice per day
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Changes on Skin microbiota 12 weeks To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis.
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.
Trial Locations
- Locations (1)
Hospital General Dr. Manuel Gea Gonzalez
🇲🇽Mexico city, Mexico