Fact CheckerSign in

NCT06463353Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 17 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
376 (estimated)
First submitted
6 Jun 2024
Start date
15 Jun 2024
Primary completion date
30 Jun 2027
Lead sponsor
Shanghai Yueyang Integrated Medicine Hospital
NCT number
NCT06463353

What you commit to

  • Study type: Interventional
  • Planned participants: 376
  • From 15 Jun 2024 to the primary completion date, 30 Jun 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 illness

  • 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 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;

Other

  • Patients who are currently participating in other clinical studies or have participated in other clinical studies within 1 month;
  • Other reasons (e.g., poor compliance, inability to follow up as scheduled) that the investigator believes preclude enrollment.

Who the study is looking for

  • 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.

Age in the registry: 2 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.