Atopic DermatitisNCT06463353
Clinical Study of Trilinolein Cream for Prevention of Relapse in Remission of Moderate-to-severe Atopic Dermatitis.
A study testing trilinolein cream group and cream base group in people with Atopic Dermatitis, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- trilinolein cream group and cream base group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- trilinolein cream group, cream base group
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trilinolein cream groupOther
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.
cream base groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Trilinolein cream group | Experimental | receiving trilinolein cream twice a day,in the morning and evening, for a period of 12 weeks. Receives: 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. Receives: Other: cream base group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence time
number of days from start of dosing to time of relapse assessment
Measured: 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)
One of the commonly used assessment indicators for atopic dermatitis
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463353
- Sponsor's protocol ID
- 2024-134
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06463353
- Acronym / sponsor ID
- 2024-134
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trilinolein cream group | Experimental | Other: trilinolein cream groupreceiving trilinolein cream twice a day,in the morning and evening, for a period of 12 weeks. |
| cream base group | Placebo comparator | Other: cream base groupreceiving cream base twice a day,in the morning and evening, for a period of 12 weeks. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trilinolein cream groupApply 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 | Trilinolein cream group |
| cream base groupApply 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. | Other | cream base group |
Primary outcome
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)
number of days from start of dosing to time of relapse assessment
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing trilinolein cream group and cream base group in people with Atopic Dermatitis, run by Shanghai Yueyang Integrated Medicine Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact fu lun Li (18918757260, drlifulun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.