Skip to content

A multicenter, randomized, double-blind, placebo-controlled clinical trial of trilinolein cream for the prevention of remission-phase flares in moderate-to-severe atopic dermatitis

A multicenter, randomized, double-blind, placebo-controlled clinical trial of trilinolein cream for the prevention of remission-phase flares in moderate-to-severe atopic dermatitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086397
Enrollment
Unknown
Registered
2024-07-01
Start date
2024-07-02
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

atopic dermatitis

Interventions

treatment group:Topical Trilinolein cream
control group:Topical basic emollient

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients who meet the diagnostic criteria for the diagnosis of atopic dermatitis; 2.Age: 2 to 75 years (inclusive of 2 and 75 years); any gender; 3.Patients with a history of moderate-to-severe atopic dermatitis (EASI score=8; the SCORAD score=26; IGA score = 3); 4.Patients with atopic dermatitis in remission and the IGA score of skin lesions = 1 for 2 consecutive weeks; 5.All patients or guardians signed the informed consent form, of which his/her guardian signed the informed consent form for patients aged 2-8years, the patient and guardian signed the informed consent form for patients aged 8-18years, and the patient signed the informed consent form for patients aged 18-75years.

Exclusion criteria

Exclusion criteria: 1.Patients with acute onset phase of atopic dermatitis with anerosion, exudation and secondary infection; 2.Patients that are allergic to the subject product and its components; 3.Patients who are currently participating in other clinical studies or have participated in other clinical study within 1 month; 4.Patients with other skin diseases apart from atopic dermatitis in the treatment region; 5.Patients with severe liver and kidney diseases,hematologic diseases, autoimmune diseases, chronic severe infections, diabetes mellitus or mental diseases, history of drug abuse or alcohol abuse; 6.Patients with a history of malignant neoplasms and/or other severe diseases that may affect the correct assessment of the efficacy of the treatment; 7.Treatment with dopriumab and discontinued for= 12 weeks or treatment with Jak inhibitors and discontinued for=1 week; 8.Patients who have used hormones or other immunosuppressive drugs (cyclosporine, methotrexate, tretinoin, etc.) and/or phototherapy before study initiation; 9.Other reasons (e.g.,poor adherence, inability to follow up as scheduled) that the investigator believes preclude enrollment

Design outcomes

Primary

MeasureTime frame
Recurrence time;

Secondary

MeasureTime frame
Overall effective rate;EASI(Eczema area and severity index);IGA(Investigator’s Global Assessment);VAS(Visual Analog Scale);DLQI(Dermatology Life Quality Index);Total serum IGE;

Countries

China

Contacts

Public ContactLi fulun

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

drlifilun@163.com+86 189 1875 7260

Outcome results

None listed

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