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A randomized, double-blind, placebo-controlled, multicenter clinical trial of Qingpeng Ointment in the treatment of subacute eczema in children

A randomized, double-blind, placebo-controlled, multicenter clinical trial of Qingpeng Ointment in the treatment of subacute eczema in children

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116385
Enrollment
Unknown
Registered
2026-01-09
Start date
2025-12-29
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Childhood subacute eczema

Interventions

experimental group:Use Qingpeng Ointment to test the drug (Qingpeng Ointment)
control group:Use Qingpeng ointment in comparison with the drug (the Qingpeng ointment simulant)

Sponsors

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: There are 1. those who meet the diagnostic criteria for subacute eczema; 2.those aged 2 to 12 years old; 3. those whose skin lesion body surface involvement area is = 4 points, and an IGA score of 2 or 3 points at the time of screening; 4.The informed consent process should comply with regulations, and the legal guardian or the participant (>=8 years old) together with the trial participant should sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Those with severe exudation on the affected area (EASI lesion morphology score Ei >= 2 points) or lichenoid changes (EASI lesion morphology score L >= 2 points); 2.Those with or combined with the following diseases that are difficult to distinguish from eczema, such as superficial fungal diseases, scabies, polymorphous light eruption, psoriasis, seborrheic dermatitis, irritant contact dermatitis, etc.; 3.Those who have received systemic use of glucocorticoids, immunosuppressants and ultraviolet therapy within 4 weeks before treatment, have used antihistamines within 2 weeks before treatment, and have used topical medications (such as TCS, TCI) within 1 week before treatment; 4.Those with obvious bacterial, fungal or viral infections in the lesion area; 5.Those with severe primary diseases or malignant tumors such as cardiovascular, liver, kidney, digestive, hematological and nervous system diseases; 6.Those with legally recognized disabilities (blindness, deafness, dumbness, intellectual disability, mental disorder, etc.); 7.Those who are known or suspected to be allergic to the components of the test drug; 8.Those who have participated in other interventional clinical trials within the past 3 months; 9.Those who, in the opinion of the investigator, are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The changes in the area of target lesions and the changes in the morphology scores of target lesions;Target lesion EASI score and percentage change in body surface area (BSA) of the lesion;Response rates of EASI-50, EASI-75, and EASI-90;Change in IGA score;The success rate of eczema treatment;The proportion of exacerbated eczema cases;Change value of PP-NRS score;Days for itching relief to take effect;Change in POEM score;

Countries

China

Contacts

Public ContactQing Rong

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

erke2007@163.com+86 138 2086 2076

Outcome results

None listed

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