Clinical Study of Trilinolein Cream for Prevention of Relapse in Remission of Moderate-to-severe Atopic Dermatitis.

NCT06463353 | Not Yet Recruiting

• 1 other identifier: 2024-134
• Study Type: interventional
• Target: 376
• Locations: 0 countries
• Sites: N/A

Brief Summary

This multicenter, randomized, double-blind, placebo-controlled will be conducted at Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine; Seventh People's Hospital, Shanghai University of Traditional Chinese Medicine; Jiading District Hospital of Traditional Chinese Medicine, Shanghai; and Baoshan District Hospital of Integrative Medicine, Shanghai; Huashan Hospital affiliated with Fudan University, Longhua Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, and the First Affiliated Hospital of the Naval Medical University. Approximately 376 participants will be recruited and randomly assigned to the Trilinolein cream or cream base group using block group randomization. The primary outcome will be time to relapse (number of days from the start of dosing to the time of relapse rating), and secondary outcomes will include eczema area and severity indices, overall investigator ratings, visual itch analog scores, dermatologic quality of life indices, overall improvement rates, and safety metrics. All data from the study will be analyzed using the SPSS 23.0 statistical package.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Recurrence time

  number of days from start of dosing to time of relapse assessment

  Assessed at screening period -14 ~ -1 days (V1), treatment period day 1 (V2), week 4 ± 3 days (V3), week 8 ± 3 days (V4), week 12 ± 3 days (V5) and follow-up period week 16 ± 3 days (V6)

Secondary Outcomes (9)

• Eczema Area and Severity Index(EASI)

  Assessed at screening period -14 ~ -1 days (V1), treatment period day 1 (V2), week 4 ± 3 days (V3), week 8 ± 3 days (V4), week 12 ± 3 days (V5) and follow-up period week 16 ± 3 days (V6)

• Investigator's Global Assessment(IGA)

  Assessed at screening period -14 ~ -1 days (V1), treatment period day 1 (V2), week 4 ± 3 days (V3), week 8 ± 3 days (V4), week 12 ± 3 days (V5) and follow-up period week 16 ± 3 days (V6)

• Visual Analogue Scale(VAS)

  Assessed at screening period -14 ~ -1 days (V1), treatment period day 1 (V2), week 4 ± 3 days (V3), week 8 ± 3 days (V4), week 12 ± 3 days (V5) and follow-up period week 16 ± 3 days (V6)

• Dermatology Life Quality Index(DLQI)

  Assessed at screening period -14 ~ -1 days (V1), treatment period day 1 (V2), week 4 ± 3 days (V3), week 8 ± 3 days (V4), week 12 ± 3 days (V5) and follow-up period week 16 ± 3 days (V6)

• Overall effective rate

  through study completion, an average of 16 weeks

Study Arms (2)

Trilinolein cream group

EXPERIMENTAL

receiving trilinolein cream twice a day,in the morning and evening, for a period of 12 weeks.

Other: trilinolein cream group

cream base group

PLACEBO COMPARATOR

receiving cream base twice a day,in the morning and evening, for a period of 12 weeks.

Other: cream base group

Interventions

trilinolein cream group OTHER

Apply trilinolein cream evenly to the affected skin twice daily. The dosage is calculated using Finger Tip Units (FTU) and should not exceed a maximum of 30 grams per day.

Trilinolein cream group

cream base group OTHER

Apply cream base evenly to the affected skin twice daily. The dosage is calculated using Finger Tip Units (FTU) and should not exceed a maximum of 30 grams per day.

cream base group

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a clear diagnosis of atopic dermatitis in accordance with the diagnostic criteria of Chinese and Western medicine;
• Age ≥2 years and ≤75 years; gender is not limited;
• Patients with a previous history of moderate to severe atopic dermatitis (EASI score ≥ 8, or SCORAD score ≥ 26, or IGA score ≥ 3);
• Patients were in AD remission with a skin lesion IGA score ≤ 1 for 2 consecutive weeks;
• All patients or guardians signed an informed consent form, of which the guardian signed the informed consent form for patients aged 2-8 years (\<8); the patient and guardian signed the informed consent form for patients aged 8-18 years (\<18); and the patient signed the informed consent form for patients aged 18-75 years.

You may not qualify if:

• Patients who are in the acute morbid stage and have erosion, exudation, and secondary infection;
• Patients who are allergic to the test article and its components;
• Patients who are currently participating in other clinical studies or have participated in other clinical studies within 1 month;
• Patients with skin diseases other than AD in the area to be treated;
• Patients with severe hepatic or renal diseases, hematologic disorders, autoimmune diseases, chronic severe infections, diabetes or diseases of God, drug or alcohol abuse;
• Suffering from malignant tumors or other serious diseases that may affect the correct assessment of efficacy;
• Have been treated with dupliyuzumab with a discontinuation time ≤ 12 weeks, or have been treated with a JAK inhibitor with a discontinuation time ≤ 1 week;
• Patients who have been systematically treated with hormones, other immunosuppressive agents (cyclosporine, methotrexate, reglanoside, etc.) or phototherapy;
• Other reasons (e.g., poor compliance, inability to follow up as scheduled) that the investigator believes preclude enrollment.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

fu lun Li

CONTACT

18918757260; drlifulun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 17, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 17, 2024

Record last verified: 2024-06