Atopic Dermatitis
Conditions
Interventions
Experimental group:Frog Prince Stephania Tetrandra & Camellia Oil Soothing Moisturizing Cream
Placebo group:Frog Prince Moisturizing Cream
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 12 Years
Inclusion criteria
Inclusion criteria: 1.Age: 6 months to 12 years old (<=12 years old), including no less than 15 subjects aged 6 months to 3 years old (<=3 years old), and no less than 15 subjects aged over 3 years to 12 years old (<=12 years old). 2.Gender: Not restricted. 3.Place of Residence: Has been living in Shanghai/Zhangzhou for the past 6 months. 4.Diagnosis: A child with atopic dermatitis (AD) as assessed by a physician, meeting the diagnostic criteria of the Williams criteria, and with an Eczema Area and Severity Index (EASI) score < 8. 5.Recurrence History: Parent/legal guardian reports a history of recurrent flares: at least 2 flare occurrences within the past 2 years, or for subjects under 2 years old, at least 2 flare occurrences from birth to the day of enrollment. 6.Informed Consent: Written informed consent, personally signed and dated by the subject's parent/legal guardian, providing evidence that the parent/legal guardian has been informed of all relevant aspects of the study. 7.Guardian Age: The subject's parent/legal guardian must have reached the legal age of adulthood in the country where the study is conducted. 8.Guardian Compliance: The subject's parent/legal guardian is willing and able to comply with scheduled visits and study protocol requirements, including but not limited to:Committing to strictly use the study product as directed throughout the entire study period and not using other similar products.Being able to accompany the subject to scheduled visits at the designated times.Having sufficient understanding of the study objectives, voluntarily signing the informed consent form, and cooperating with clinical follow-ups and completion of diary cards. 9.Guardian Contact: The subject's parent/legal guardian must be directly reachable by phone or email throughout the entire study process.
Exclusion criteria
Exclusion criteria: 1.Currently undergoing dermatological treatment or having used any topical medications or terpenoid substances on the observation areas within the last 5 days. 2.Presence of blisters, pustules, sores, abscesses, erosion, ulcers, tinea, wounds, cracks, or pigmented/pink skin repair areas at the observation sites. 3.Current use of topical or systemic corticosteroids, antihistamines, anti-inflammatory drugs, or related biologics that may cause adverse events or affect trial results, including: Systemic use of immunosuppressants, steroids, or biologics within 3 months before testing or during the trial. Use of antihistamines on any part of the body within 1 month before testing or during the trial. 4.Patients with asthma or other chronic respiratory diseases currently under treatment. 5.Having taken/injected anti-allergy medications within the past 1 month. 6.History of skin symptoms or allergic reactions (e.g., erythema, edema, papules) triggered by cosmetics, drugs, etc. 7.History of other skin conditions that may affect the trial (e.g., pigmented spots, psoriasis, acne affecting assessment at the evaluation site). 8.Suffering from or having a history of digestive, hepatic, renal, circulatory, hematological, endocrine diseases, or suspected malignant tumors, or showing significant symptoms of such conditions. 9.Presence of unhealed open wounds at the observation sites. 10.The subject's legal guardian/parent or family member works in fields such as pharmaceutical production, cosmetics production, market research, or advertising. 11.Participation in another cosmetic or pharmaceutical clinical trial, survey, or product testing within 3 months before the trial start or currently enrolled in such a study. 12. Having taken a bath within 24 hours before the trial start or having applied any substances (lotions, perfumes, cosmetics, etc.) to the skin. 13.Other circumstances deemed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence Rate;Cytokine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Recurrence;Moisture content of skin stratum corneum;Skin water loss through epidermis;Skin PH;Skin Hemoglobin Content;Skin Texture;Microecological detection; | — |
Countries
China
Contacts
Public ContactChao Yuan
Shanghai Skin Disease Hospital
Outcome results
None listed