Clinical Study of Trilinolein Cream for Prevention of Relapse in Remission of Moderate-to-severe Atopic Dermatitis.
NCT Number: NCT06463353
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atopic Dermatitis
Interventions: OTHER: trilinolein cream group|OTHER: cream base group
Sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 376
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-15
Completion Date: 2027-11-30

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.

Primary Outcome Measures: 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 Outcome Measures: Eczema Area and Severity Index(EASI), One of the commonly used assessment indicators for atopic dermatitis, 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), One of the commonly used assessment indicators for atopic dermatitis, 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), One of the commonly used assessment indicators for atopic dermatitis, 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), One of the commonly used assessment indicators for atopic dermatitis, 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, Difference between pre- and post-treatment EASI scores/baseline EASI score × 100%, where ≥90% is considered cured, 60% \~ 89% is considered effective, 20% \~ 59% is considered improved, and \<20% is considered ineffective, and the total of the cured rate and the effective rate is the overall effective rate., through study completion, an average of 16 weeks|Total serum IgE, Peripheral blood samples are collected from patients by sub-centers and uniformly sent for testing by the main center., 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), Indicators for objective evaluation of treatment, 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, Detecting changes in flora species and diversity, Assessed at treatment period day 1 (V2) and follow-up period week 16 ± 3 days (V6)|Safety evaluation indicators, Record adverse events in detail at any time, and record any adverse reactions such as hyperpigmentation, capillary dilatation and skin atrophy at the site of application during the period of drug administration, up to 12 weeks