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A repair cream containing special ingredients (Artemisia annua extract and rice grain extract) on the improvement of skin lesions and the effect on the skin barrier in patients >=aged 29 days to <= 3 years of age with mild to moderate atopic dermatitis

A repair cream containing special ingredients (Artemisia annua extract and rice grain extract) on the improvement of skin lesions and the effect on the skin barrier in patients >=aged 29 days to <= 3 years of age with mild to moderate atopic dermatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071448
Enrollment
Unknown
Registered
2023-05-16
Start date
2023-05-15
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Atopic dermatitis

Interventions

Experimental group:Topical use of a repair cream containing special ingredients (Artemisia annua extract and rice grain extract) at least 2 times/day with an amount of 100g/week
Blank control group:None

Sponsors

Beijing Children's Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Test group: (1) Age >= 29 days and = 29 days and <= 3 years old, male or female; (2) Consciously healthy, no personal history of atopic dermatitis and other allergic skin diseases, food allergies, allergic rhinitis, asthma, etc., and family history of allergic diseases within two generations; (3) No history of serious systemic diseases such as digestive system diseases, chronic infections, kidney diseases, rheumatic diseases, metabolic and malnutrition, thyroid diseases, blood system diseases, malignant tumors, hypertension, etc.; (4) Have not had surgery, blood donation, blood transfusion or extensive blood loss in the past one year; (5) No systematic use of glucocorticoids, immunosuppressants or traditional Chinese medicine treatment within one month before the start of the trial; (6) The test area has not been cleaned in the past 24 hours, no skin care products have been applied for 3 days, and no other external drugs have been applied in 2 weeks.

Exclusion criteria

Exclusion criteria: 1. Test group: (1) Children with skin diseases other than atopic dermatitis in the area requiring treatment; (2) Children in the acute onset period and erosion, exudation, and secondary infection; (3) Children who have participated in clinical trials of other drugs or medical devices in the past 3 months; (4) Children who are known to be allergic to any ingredient in the test product; (5) Discontinuation of emollients before enrollment< 3 days; Antihistamine discontinuation time< 1 week; topical corticosteroids or other immunosuppressants < 2 weeks; Systematic corticosteroids and other immunosuppressants (cyclosporine, methotrexate, triptovine, biological agents, etc.) discontinuation time < 4 weeks; (6) Children with serious systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, genitourinary system diseases, etc.) and immunodeficiency diseases; (7) Children with scabies, seborrheic dermatitis, allergic contact dermatitis, ichthyosis, cutaneous lymphoma, psoriasis and congenital immunodeficiency; (8) Those who have poor compliance with the subjects, or are known to be unable to participate in follow-up visits on time, or are unwilling to comply with the research protocol during the study; (9) Children judged by the investigator to be unsuitable for participating in this clinical trial. 2. the blank control group: (1) Current or previous abnormal eosinophil count test results (outside the normal reference range); (2) Those who participated in other clinical project researchers during the same period; (3) Patients who are considered unsuitable for participation in this study by other study physicians.

Design outcomes

Secondary

MeasureTime frame
Transepidermal water loss (TEWL);Epidermal water content;Skin pH;Microbiome detection of lesions;Lipid metabolism testing of lesions;

Countries

China

Contacts

Public ContactMa Lin

Beijing Children's Hospital Affiliated to Capital Medical University

bch_maleen2021@126.com+86 136 0130 5676

Outcome results

None listed

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