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A Phase II, Placebo-controlled Trial Evaluating the Efficacy of Antroquinonol in Patients With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT04110873
Recruitment Status : Terminated (It was hard to find suitable subject due to strict enrollment criteria.)
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Golden Biotechnology Corporation
Information provided by (Responsible Party):
Cheng-Chung Wei, Chung Shan Medical University

Tracking Information
First Submitted Date  ICMJE September 30, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE July 27, 2018
Actual Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Eczema Area and Severity Index (EASI) at each time point [ Time Frame: week 0(baseline), week 4, week8 and week12 ]
    Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the EASI score
  • Scoring Atopic Dermatitis (SCORAD) [ Time Frame: week 0(baseline), week 4, week8 and week12 ]
    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
  • static Investigator's Global Assessment (sIGA) [ Time Frame: week 0(baseline), week 4, week8 and week12 ]
    Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the sIGA score
  • Body-surface area affected by atopic dermatitis [ Time Frame: week 0(baseline), week 4, week8 and week12 ]
    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
  • Pruritus verbal rating scale [ Time Frame: week 0(baseline), week 4, week8 and week12 ]
    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
  • Sleep-disturbance visual-analogue scale [ Time Frame: week 0(baseline), week 4, week8 and week12 ]
    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
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 30, 2019)
The percentage change between baseline and week 12 in serum cytokines [ Time Frame: week 0(baseline) and week12 ]
The percentage change between baseline and week 12 in serum cytokines: TARC/CCL17, IFN-gamma, TNF-alpha, IL-18, IL-6, IL-1beta
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase II, Placebo-controlled Trial Evaluating the Efficacy of Antroquinonol in Patients With Atopic Dermatitis
Official Title  ICMJE A Phase II, Three-arms, Double-blind, Dosing-ranging, Placebo-controlled Trial Evaluating the Efficacy of Antroquinonol in Patients With Atopic Dermatitis
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Antroquinonol Capsule 50mg
    patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks
    Other Name: Antroquinonol 50mg
  • Drug: Antroquinonol Capsule 100mg
    patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks
    Other Name: Antroquinonol 100mg
  • Drug: Placebo oral capsule
    patients will receive placebo per day (QD) on Day 1 for 12 weeks
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Antroquinonol capsule 50mg
    patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks
    Intervention: Drug: Antroquinonol Capsule 50mg
  • Experimental: Antroquinonol capsule 100mg
    patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks
    Intervention: Drug: Antroquinonol Capsule 100mg
  • Placebo Comparator: Placebo oral capsule
    patients will receive placebo per day (QD) on Day 1 for 12 weeks
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 30, 2019)
14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 25, 2019
Actual Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients between the ages of 20 and 65 years who had moderate-to-severe atopic dermatitis (using the Hanifin and Rajka Diagnostic Criteria)
  2. Patients with body weight ≥ 25 kg and ≤ 120 kg, signing informed consent
  3. To be eligible to participate, patients were required to have

    1. 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;
    2. 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);
    3. a score of at least 2 on the static Investigator's Global Assessment (sIGA), which ranges from 0 (clear) to 4 ( severe disease).
    4. BSA affected or PSAI ≥ 5%

Exclusion Criteria:

Patients meeting any of the following criteria must not be enrolled in the study:

  1. Patients with active dermatologic diseases concomitant with atopic dermatitis.
  2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  3. Subjects with defective epidermal barrier(e.g Netherton's syndrome)
  4. 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.
  5. 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
  6. 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.
  7. Ongoing participation in another investigational trial
  8. 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
  9. Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks of the Treatment visit.
  10. 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.
  11. Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices.
  12. History of food or drug-related severe anaphylactoid or anaphylactic reaction(s)
  13. Pregnancy or breastfeeding
  14. History or presence of epilepsy, significant neurological disorders, cerebrovascular attack or ischemia
  15. History or presence of myocardial infarction or cardiac arrhythmia under drug therapy
  16. Patients who are unable to complete questionnaires on paper.
  17. Clinically significant laboratory abnormalities.
  18. History of malignancy of any organ system, treated or untreated.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04110873
Other Study ID Numbers  ICMJE CS17155
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cheng-Chung Wei, Chung Shan Medical University
Study Sponsor  ICMJE Chung Shan Medical University
Collaborators  ICMJE Golden Biotechnology Corporation
Investigators  ICMJE
Principal Investigator: Wei C- C, M.D. Chung Shan Medical University
PRS Account Chung Shan Medical University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP