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

Official title

A Multicenter, Randomized, Double-blind, Controlled Clinical Study of Xia's Dermatology Method of Nourishing Blood and Moistening Dryness to Prevent Relapse in Remission of Moderate-to-severe Atopic Dermatitis

Overview

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.

Detailed description

This randomized, double-blind, placebo-controlled trial will be conducted at 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, the First Affiliated Hospital of Naval Military Medical University, Yueyang Hospital of Traditional Chinese Medicine and Western Combined Hospital affiliated with Shanghai University of Traditional Chinese Medicine, the Seventh People's Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai Jiading Hospital of Traditional Chinese Medicine, and the Combined Hospital of Traditional Chinese Medicine and Western Combined Hospital of Baoshan District of Shanghai. . The trial will start after ethical approval and protocol registration. Patient recruitment started in June 20234 and is expected to end in March 20257 . It is anticipated that 376 participants will be enrolled in the trial and randomly assigned in a 1:1 ratio to receive treatment with Trilinolein cream or cream base. The Standards for Reporting Interventions in Acupuncture Clinical Trials (STRICTA) and the SPIRIT Reporting Guidelines will be followed in the development of the standard protocol to clearly and transparently explain the relevant treatment processes.

Potential subjects will be evaluated for eligibility to determine if inclusion and exclusion criteria are met. Eligible subjects will voluntarily provide written informed consent prior to randomization.

The study will have a double-blind design.Trilinolein cream and cream base will be supplied by the manufacturer, registered, and then distributed by the designated investigator at the time of the visit. Unused cream will be collected and counted after each distribution except for the first distribution.

Interventions

• Other trilinolein cream group
  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.
• Other cream base group
  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.

Primary outcome measures

• Recurrence time [Time frame: 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 outcome measures (9)

• Eczema Area and Severity Index(EASI) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: through study completion, an average of 16 weeks]
• Total serum IgE [Time frame: Assessed at screening period -14 ~ -1 days (V1), treatment period week 4 ± 3 days (V3), week 12 ± 3 days (V5)]
• Trans Epidermal Water Loss(TEWL) [Time frame: 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)]
• Skin flora test [Time frame: Assessed at treatment period day 1 (V2) and follow-up period week 16 ± 3 days (V6)]
• Safety evaluation indicators [Time frame: up to 12 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06463353 · 2024-134

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗