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Trial record 2 of 9 for:    antroquinonol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Antroquinonol Capsule 50mg Drug: Antroquinonol Capsule 100mg Drug: Placebo oral capsule Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Three-arms, Double-blind, Dosing-ranging, Placebo-controlled Trial Evaluating the Efficacy of Antroquinonol in Patients With Atopic Dermatitis
Actual Study Start Date : July 27, 2018
Actual Primary Completion Date : June 25, 2019
Actual Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Antroquinonol capsule 50mg
patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks
Drug: Antroquinonol Capsule 50mg
patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks
Other Name: Antroquinonol 50mg

Experimental: Antroquinonol capsule 100mg
patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks
Drug: Antroquinonol Capsule 100mg
patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks
Other Name: Antroquinonol 100mg

Placebo Comparator: Placebo oral capsule
patients will receive placebo per day (QD) on Day 1 for 12 weeks
Drug: Placebo oral capsule
patients will receive placebo per day (QD) on Day 1 for 12 weeks
Other Name: Placebo




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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


Other Outcome Measures:
  1. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110873


Locations
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Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
Sponsors and Collaborators
Chung Shan Medical University
Golden Biotechnology Corporation
Investigators
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Principal Investigator: Wei C- C, M.D. Chung Shan Medical University
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Responsible Party: Cheng-Chung Wei, Chung Shan Medical University Hospital, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT04110873    
Other Study ID Numbers: CS17155
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheng-Chung Wei, Chung Shan Medical University:
antroquinonol, Atopic dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs