Atopic DermatitisPhase 2NCT04110873
A Phase II, Placebo-controlled Trial Evaluating the Efficacy of Antroquinonol in Patients With Atopic Dermatitis
A Phase 2 study testing Antroquinonol Capsule 50mg and Antroquinonol Capsule 100mg in people with Atopic Dermatitis, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Primary Objective: To evaluate the activity of Antroquinonol in patients with atopic dermatitis. Secondary Objective: To assess the mechanism and cytokines change of Antroquinonol in patients with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Antroquinonol Capsule 50mg and Antroquinonol Capsule 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jul 2018to 25 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 20 and 65 years who had moderate-to-severe atopic dermatitis (using the Hanifin and Rajka Diagnostic Criteria)
- Patients with body weight ≥ 25 kg and ≤ 120 kg, signing informed consent
- To be eligible to participate, patients were required to have
- a score of at least 5 on the Eczema Area and Severity Index (EASI), which ranges from 0 to 72, with higher scores indicating worse disease severity;
- a score for pruritus of at least 30 mm on a visual-analogue scale, which ranges from 0 (no itch) to 100 mm (worst itch imaginable);
- a score of at least 2 on the static Investigator's Global Assessment (sIGA), which ranges from 0 (clear) to 4 ( severe disease).
- BSA affected or PSAI ≥ 5%
Who cannot join
- Patients meeting any of the following criteria must not be enrolled in the study:
- Patients with active dermatologic diseases concomitant with atopic dermatitis.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Subjects with defective epidermal barrier(e.g Netherton's syndrome)
- Any subject who is immunocompromised or has a history of malignant disease. This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test.
- Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
Show all 19Show fewer
- Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
- Ongoing participation in another investigational trial
- Use of any oral or topical antibiotic for up to four weeks prior to the Treatment visit or active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks of the Treatment visit.
- Participant who has a condition or is in a situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.
- Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices.
- History of food or drug-related severe anaphylactoid or anaphylactic reaction(s)
- Pregnancy or breastfeeding
- History or presence of epilepsy, significant neurological disorders, cerebrovascular attack or ischemia
- History or presence of myocardial infarction or cardiac arrhythmia under drug therapy
- Patients who are unable to complete questionnaires on paper.
- Clinically significant laboratory abnormalities.
- History of malignancy of any organ system, treated or untreated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Three-arms, Double-blind, Dosing-ranging, Placebo-controlled Trial Evaluating the Efficacy of Antroquinonol in Patients With Atopic Dermatitis
Primary Objective:
To evaluate the activity of Antroquinonol in patients with atopic dermatitis.
Secondary Objective:
To assess the mechanism and cytokines change of Antroquinonol in patients with atopic dermatitis.
Exploratory Objective:
To explore potential relationships between Antroquinonol exposure and safety and efficacy endpoints.
Read the detailed description
This is a Phase II, three-arms, double-blind, dosing-ranging, placebo-controlled trial evaluating the efficacy of Antroquinonol in patients with atopic dermatitis. The study is conducted in compliance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. Approval is obtained from the local ethics committee or institutional review board at each study center. All the patients provided written informed consent.
60 patients totally (20 patients per arm) with atopic dermatitis will receive Antroquinonol or placebo. A patient will have received at one dose of Antroquinonol or placebo with tropical urea ointment and have three baseline scores assessment (see Statistical Methods). Enrollment will continue until the target number of evaluable patients has been enrolled.
Written informed consent must be obtained from all patients before initiating Screening. The Screening period will be up to 14 days in duration (Days -14 to -1). Following completion of all Screening assessments and confirmation of eligibility criteria, patients will receive Antroquinonol 50mg, 100mg or placebo per day (QD) on Day 0 for 12 weeks or until documented evidence of unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first. The time of study drug administration should be recorded in the patient diary.
Patients will attend study visits on Days 0, 28, 56 and 84. The following procedures will be performed according to the schedule of assessments: physical examination, vital signs, performance status, clinical laboratory tests, adverse events (AEs), concomitant medication and patient compliance.
Scores assessments will be performed at Screening, Day 28, Day 56 and Day 84 including EASI score, SCORAD, sIGA score, BSA affected by atopic dermatitis and pruritus verbal rating scale.
The primary endpoint is the percentage improvement between baseline and week 12 in Eczema Area and Severity Index (EASI).
- Conditions
- Atopic Dermatitis
- Being tested
- Antroquinonol Capsule 50mg, Antroquinonol Capsule 100mg, Placebo oral capsule
- Keywords
- antroquinonol, Atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antroquinonol Capsule 50mgDrug
Also called Antroquinonol 50mg
patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks
Antroquinonol Capsule 100mgDrug
Also called Antroquinonol 100mg
patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks
Placebo oral capsuleDrug
Also called Placebo
patients will receive placebo per day (QD) on Day 1 for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Antroquinonol capsule 50mg | Experimental | patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks Receives: Drug: Antroquinonol Capsule 50mg |
| Antroquinonol capsule 100mg | Experimental | patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks Receives: Drug: Antroquinonol Capsule 100mg |
| Placebo oral capsule | Placebo comparator | patients will receive placebo per day (QD) on Day 1 for 12 weeks Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI)
The percentage improvement between week 0(baseline) and week 12 in Eczema Area and Severity Index (EASI)
Measured: week 0(baseline) and week12
Secondary outcomes (11)
Eczema Area and Severity Index (EASI) at each time point
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the EASI score
Measured: week 0(baseline), week 4, week8 and week12
Scoring Atopic Dermatitis (SCORAD)
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the Scoring Atopic Dermatitis (SCORAD), which ranges from 0 to 103, with higher scores indicating more severe disease
Measured: week 0(baseline), week 4, week8 and week12
static Investigator's Global Assessment (sIGA)
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the sIGA score
Measured: week 0(baseline), week 4, week8 and week12
Body-surface area affected by atopic dermatitis
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the Body-surface area affected by atopic dermatitis
Measured: week 0(baseline), week 4, week8 and week12
Pruritus verbal rating scale
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the Pruritus verbal rating scale, which describes pruritus intensity from 0 (none) to 10(very severe) daily
Measured: week 0(baseline), week 4, week8 and week12
Sleep-disturbance visual-analogue scale
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the Sleep-disturbance visual-analogue scale, which ranges from 0 (no sleep disturbance) to 10 (inability to sleep at all) daily
Measured: week 0(baseline), week 4, week8 and week12
The proportion of patients with 25%, 50%, and 75% improvement in scores on the pruritus visual-analogue scale
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with 25%, 50%, and 75% improvement in scores on the pruritus visual-analogue scale
Measured: week 0(baseline), week 4, week8 and week12
The proportion of patients with 25%, 50%, and 75% improvement in scores on the EASI
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with 25%, 50%, and 75% improvement in scores on the EASI
Measured: week 0(baseline), week 4, week8 and week12
The proportion of patients with 25%, 50%, and 75% improvement in scores on the SCORAD
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with 25%, 50%, and 75% improvement in scores on the SCORAD
Measured: week 0(baseline), week 4, week8 and week12
The proportion of patients with an improvement of at least 2 points on the sIGA
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with an improvement of at least 2 points on the sIGA
Measured: week 0(baseline), week 4, week8 and week12
The proportion of patients with an improvement of at least 2 points on the pruritus verbal rating scale
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with an improvement of at least 2 points on the pruritus verbal rating scale
Measured: week 0(baseline), week 4, week8 and week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start27 Jul 2018
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Why it stopped: It was hard to find suitable subject due to strict enrollment criteria.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Golden Biotechnology Corporation
- Responsible party
- Principal investigator, Cheng-Chung Wei, Chung Shan Medical University
- Investigators
- Wei C- C, M.D., Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110873
- Sponsor's protocol ID
- CS17155
- Status last verified
- Sep 2019
- First submitted
- 30 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Three-arms, Double-blind, Dosing-ranging, Placebo-controlled Trial Evaluating the Efficacy of Antroquinonol in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04110873
- Acronym / sponsor ID
- CS17155
- Conditions
- Atopic Dermatitis
- Keywords
- antroquinonol, Atopic dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was hard to find suitable subject due to strict enrollment criteria.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- Golden Biotechnology Corporation
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 1 Oct 2019 (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.
Primary Objective:
To evaluate the activity of Antroquinonol in patients with atopic dermatitis.
Secondary Objective:
To assess the mechanism and cytokines change of Antroquinonol in patients with atopic dermatitis.
Exploratory Objective:
To explore potential relationships between Antroquinonol exposure and safety and efficacy endpoints.
Detailed description
This is a Phase II, three-arms, double-blind, dosing-ranging, placebo-controlled trial evaluating the efficacy of Antroquinonol in patients with atopic dermatitis. The study is conducted in compliance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. Approval is obtained from the local ethics committee or institutional review board at each study center. All the patients provided written informed consent.
60 patients totally (20 patients per arm) with atopic dermatitis will receive Antroquinonol or placebo. A patient will have received at one dose of Antroquinonol or placebo with tropical urea ointment and have three baseline scores assessment (see Statistical Methods). Enrollment will continue until the target number of evaluable patients has been enrolled.
Written informed consent must be obtained from all patients before initiating Screening. The Screening period will be up to 14 days in duration (Days -14 to -1). Following completion of all Screening assessments and confirmation of eligibility criteria, patients will receive Antroquinonol 50mg, 100mg or placebo per day (QD) on Day 0 for 12 weeks or until documented evidence of unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first. The time of study drug administration should be recorded in the patient diary.
Patients will attend study visits on Days 0, 28, 56 and 84. The following procedures will be performed according to the schedule of assessments: physical examination, vital signs, performance status, clinical laboratory tests, adverse events (AEs), concomitant medication and patient compliance.
Scores assessments will be performed at Screening, Day 28, Day 56 and Day 84 including EASI score, SCORAD, sIGA score, BSA affected by atopic dermatitis and pruritus verbal rating scale.
The primary endpoint is the percentage improvement between baseline and week 12 in Eczema Area and Severity Index (EASI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antroquinonol capsule 50mg | Experimental | Drug: Antroquinonol Capsule 50mgpatients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks |
| Antroquinonol capsule 100mg | Experimental | Drug: Antroquinonol Capsule 100mgpatients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsulepatients will receive placebo per day (QD) on Day 1 for 12 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients between the ages of 20 and 65 years who had moderate-to-severe atopic dermatitis (using the Hanifin and Rajka Diagnostic Criteria)
- Patients with body weight ≥ 25 kg and ≤ 120 kg, signing informed consent
- To be eligible to participate, patients were required to have
Key exclusion criteria (19 listed)
- Patients with active dermatologic diseases concomitant with atopic dermatitis.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Subjects with defective epidermal barrier(e.g Netherton's syndrome)
- Any subject who is immunocompromised or has a history of malignant disease. This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test.
- Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
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 |
|---|---|---|
| Antroquinonol Capsule 50mgAlso: Antroquinonol 50mgpatients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks | Drug | Antroquinonol capsule 50mg |
| Antroquinonol Capsule 100mgAlso: Antroquinonol 100mgpatients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks | Drug | Antroquinonol capsule 100mg |
| Placebo oral capsuleAlso: Placebopatients will receive placebo per day (QD) on Day 1 for 12 weeks | Drug | Placebo oral capsule |
Primary outcome
Eczema Area and Severity Index (EASI)
Time frame: week 0(baseline) and week12
The percentage improvement between week 0(baseline) and week 12 in Eczema Area and Severity Index (EASI)
11 secondary outcomes
Eczema Area and Severity Index (EASI) at each time point
Time frame: week 0(baseline), week 4, week8 and week12
Scoring Atopic Dermatitis (SCORAD)
Time frame: week 0(baseline), week 4, week8 and week12
static Investigator's Global Assessment (sIGA)
Time frame: week 0(baseline), week 4, week8 and week12
Body-surface area affected by atopic dermatitis
Time frame: week 0(baseline), week 4, week8 and week12
Pruritus verbal rating scale
Time frame: week 0(baseline), week 4, week8 and week12
Sleep-disturbance visual-analogue scale
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with 25%, 50%, and 75% improvement in scores on the pruritus visual-analogue scale
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with 25%, 50%, and 75% improvement in scores on the EASI
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with 25%, 50%, and 75% improvement in scores on the SCORAD
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with an improvement of at least 2 points on the sIGA
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with an improvement of at least 2 points on the pruritus verbal rating scale
Time frame: week 0(baseline), week 4, week8 and week12
Results and safety
The study was stopped early (reason given: It was hard to find suitable subject due to strict enrollment criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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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. This study is not recruiting at the moment.
Wei C- C, M.D. principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antroquinonol Capsule 50mg and Antroquinonol Capsule 100mg in people with Atopic Dermatitis, run by Chung Shan Medical University at 1 site in Taiwan.
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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It was hard to find suitable subject due to strict enrollment criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) (time frame: week 0(baseline) and week12). 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 1 Oct 2019; AzTrials last refreshed its copy on 1 Nov 2026.