Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463353
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-06
Brief Title:
Clinical Study of Trilinolein Cream for Prevention of Relapse in Remission of Moderate-to-severe Atopic Dermatitis
Sponsor:
Shanghai Yueyang Integrated Medicine Hospital
Organization:
Shanghai Yueyang Integrated Medicine Hospital
Study Overview
Official Title:
A Multicenter Randomized Double-blind Controlled Clinical Study of Xias Dermatology Method of Nourishing Blood and Moistening Dryness to Prevent Relapse in Remission of Moderate-to-severe Atopic Dermatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Peoples 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 230 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 Peoples 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 11 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 designTrilinolein 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
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 designTrilinolein 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None