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New Moisturizing Cream containing pre- and post-biotics in the skin bacteria of patients with Atopic Dermatitis

New Moisturizing Cream containing pre- and post-biotics in the skin microbiome of patients with Atopic Dermatitis: a pilot study of therapeutic intervention, randomized, prospective, comparative, parallel-group, double-blind, placebo-controlled

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-7pbwhnv
Enrollment
Unknown
Registered
2024-06-03
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis

Interventions

After approval of the research project by the Research Ethics Committee UNIFESP and signing of the Informed Consent Form and Assent Form (under eighteen years), fifty patients with mild atopic dermati
calculation of SCORAD
capture of photographs and evaluation of disease activity perception using the Visual Analog Scale by the research participant. After the end of treatment, participan
E04.936.537

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: Signature of the Informed Consent Form (ICF) and Assent Form before any study procedures; Patients of any gender, aged one to fourteen years old; Clinical diagnosis of mild atopic dermatitis (SCORAD less or equal to 20). Eczematous lesions present in the antecubital fossae

Exclusion criteria

Exclusion criteria: Patients or guardians who do not agree with the study conditions or lack the capacity to understand and strictly follow the received instructions, without availability to attend reassessments, or who refuse to sign the Informed Consent Form (ICF) and Assent Form; non-agreement to sign the Photography Authorization Form will not be a reason for exclusion from the study; Pregnant or lactating women; Moderate and severe atopic dermatitis; Immunosuppression or genodermatoses, such as Netherton syndrome; Chlorine bath in the last week; Use of topical corticosteroids or calcineurin inhibitors in the last two weeks; Use of topical or oral antibiotics in the last thirty days; Use of oral immunosuppressive medications in the last thirty days; Use of immunobiologics in the last sixteen weeks; Use of phototherapy in the last thirty days; Active bacterial, viral, or fungal skin infections; Hypersensitivity to any component of the formulation

Design outcomes

Primary

MeasureTime frame
Evaluate the reduction of S. aureus bacteria concentration and increase of S. epidermidis bacteria concentration on the injured skin in the antecubital fossae with the use of a new moisturizing cream

Secondary

MeasureTime frame
Reduction of SCORAD by more than 50%; Clinical improvement as perceived subjectively by the patient through the Visual Analog Scale; Absence of adverse events or occurrence of mild adverse events

Countries

Brazil

Contacts

Public ContactHeloísa Freixo

Universidade Federal de São Paulo

heloisa.avo@unifesp.br+551133854100 VOIP 1746

Outcome results

None listed

Source: REBEC (via WHO ICTRP)