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Efficacy of natural weak acid repair cream in the treatment of infantile atopic dermatitis and its effect on microecology

Efficacy of natural weak acid micromolecule and macromolecule repair cream in the treatment of infantile atopic dermatitis and its effect on skin, oral cavity and intestinal microecology:a multicenter prospective randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101011
Enrollment
Unknown
Registered
2025-04-18
Start date
2025-04-19
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

atopic dermatitis

Interventions

Intervention Group 1:Children with mild to moderate atopic dermatitis treated with natural weak acid micromolecule and macromolecule repair cream of Qiyijia
Control Group 1:Children with mild to moderate atopic dermatitis treated with children moisturizing essence cream of Shunfeng Baby
Control Group 2:Children with mild-to-moderate atopic dermatitis treated with topical 0.1% mometasone furoate cream
Intervention Group 2:Children with severe atopic dermatitis treated with natural weak acid micromolecule and macromolecule repair cream and moisturizing essence cream
Control Group 3:Children with severe atopic dermatitis treated with topical 0.1% mometasone furoate cream and moisturizing essence cream
Control Group 4:Children with severe atopic dermatitis treated with natural weak acid micromolecule and macromolecule repair cream and 0.1% mometasone furoate cream
Blank control group:none

Sponsors

The First Affiliated Hospital,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1.Children with atopic dermatitis met the Yao's criteria for atopic dermatitis in Chinese children; 2.Mild to moderate atopic dermatitis (EASI score 21.1); 3.Children of both sexes with atopic dermatitis were 0-3 years old; 4.Children with atopic dermatitis were not allowed to use other skin care products throughout the study period; 5.Guardians of children with atopic dermatitis volunteered to administer the test products to the subjects according to the instructions of doctors throughout the study period and signed informed consent; 6.Normal healthy children of both sexes were 0-3 years old; 7.Normal healthy children did not use natural weak acid size molecule repair cream, moisturizer, or topical glucocorticoids within 2 weeks before the study; 8.Guardians of normal healthy children must ensure that subjects do not apply any skin care products to their skin for 24 hours prior to the assessment;

Exclusion criteria

Exclusion criteria: 1.Children with atopic dermatitis who have severe systemic diseases such as severe heart, liver, or kidney diseases or diseases that damage the immune system (such as lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome) or a history of malignant tumors; 2.Children with atopic dermatitis have skin conditions other than atopic dermatitis in the area requiring treatment; 3.Children with atopic dermatitis who are known to be allergic to natural weak Acid size Molecular repair cream or any of its components; 4.Children with atopic dermatitis had participated in a similar clinical study, and the researcher judged that the child had poor compliance and could not complete the study as required; 5.Normal healthy children suffered from cardiovascular and cerebrovascular diseases, urinary system, digestive system, nervous system, endocrine system, congenital diseases and acute and chronic infectious diseases; 6.Normal healthy children who did not wish to participate in this project;

Design outcomes

Primary

MeasureTime frame
Overall improvement rate;

Secondary

MeasureTime frame
Changes in quality of life;Changes in skin lesions;Changes in microecology;Changes in blood and urine metabolomics;Effects on growth and development;

Countries

China

Contacts

Public ContactLiu Wangkai

The First Affiliated Hospital,Sun Yat-sen University

kaidoctor@126.com+86 18620222800

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026