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Clinical observation of fluticasone propionate cream 0.05% wet package therapy versus hydrocortisone butyrate cream wet package therapy in the treatment of moderate to severe AD in children

Clinical observation of fluticasone propionate cream 0.05% wet package therapy versus hydrocortisone butyrate cream wet package therapy in the treatment of moderate to severe AD in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053251
Enrollment
Unknown
Registered
2021-11-17
Start date
2022-02-17
Completion date
Unknown
Last updated
2022-10-17

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 1:Wet-wrap treatment with fluticasone propionate cream 0.05%
Experimental group 2:Wet-wrap treatment with hydrocortisone butyrate 0.1% cream
Experimental group 3:0.05% Fluticasone propionate cream for external application

Sponsors

Dermatology Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 4-14 years, in hospital and outpatient departments, no gender limitation; 2. Clinical diagnosis meets AD (Hanifin and Rajka diagnostic criteria); 3. Lesions affected area >= 10% BSA; 4. Moderate AD: SCORAD 25-50, severe AD: SCORAD > 50; 5. The patients and their guardians voluntarily participate in the study, sign informed consent, and agree to timely visit the researcher during the study as required.

Exclusion criteria

Exclusion criteria: 1. Patients with mild AD: SCORAD0-24(BSA < 10%); 2. Known allergic history to test drugs or drugs with similar chemical structure; 3. Other diseases that cause abnormal levels of plasma cortisol and ACTH; 4. Patients with other skin diseases (such as psoriasis, etc.) or atopic dermatitis in the skin area considered by researchers to affect the determination of skin lesions; 5. Patients who have systematically used steroids or immunosuppressants in the past 4 weeks; 6. Active systemic or local infections of clinical significance, including but not limited to secondary infections of atopic dermatitis, local bacterial, viral and fungal infections, etc.; 7. Patients with obviously low immune system function and chronic diseases such as diabetes; 8. There are obvious skin atrophy and hair folliculitis in the lesions, which may affect the judgment of drug safety.

Design outcomes

Primary

MeasureTime frame
Eczema area and severity index;Plasma cortisol and adrenocorticotropic hormone;

Secondary

MeasureTime frame
Skin pH test;Transepidermal water loss;The invesitigator's global assessment;Itch number rating scale;Pediatric Dermatology Quality of Life Index;Blood routine examination;Total IgE;

Countries

China

Contacts

Public ContactLiang Yunsheng

Dermatology Hospital of Southern Medical University

yunshengliang@sohu.com+86 15973189908

Outcome results

None listed

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