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Trial record 3 of 9 for:    antroquinonol

A Trial 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: NCT03622463
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Golden Biotechnology Corporation

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date August 29, 2019
Actual Study Start Date  ICMJE July 17, 2018
Actual Primary Completion Date July 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
EASI value [ Time Frame: 12 weeks ]
Eczema Area and Severity Index: Each body region has potentially 100% involvement. Using the table below, give each respective body region a score of between 0 and 6 based on the percentage involvement. Precise measurements are not required. % involvement 0 1-9% 10 - 29% 30 - 49% 50 - 69% 70 - 89% 90 - 100% Region score 0 1 2 3 4 5 6
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
SCORAD [ Time Frame: 12 weeks ]
Scoring Atopic Dermatitis which ranges from 0 to 103, with higher scores indicating more severe disease
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Antroquinonol in Patients With Atopic Dermatitis
Official Title  ICMJE A Randomized, Double-Blind, Placebo-controlled Trial of Antroquinonol in Patients With Atopic Dermatitis
Brief Summary This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis.Duration of treatment is 12 week in total. Study visits will occur every 4 weeks. AEs/SAEs, changes to concomitant medications will be noted, vital signs will be taken, and efficacy evaluations will be performed as well. The last estimation of variable scores will occur for all subjects.
Detailed Description This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis.Duration of treatment is 12 week in total. Study visits will occur every 4 weeks. During these visits study drug will be administered at the site, new AEs/SAEs as well as follow-up for AEs and SAEs that have not been resolved will be recorded, changes to concomitant medications will be noted, vital signs will be taken, and efficacy evaluations will be performed as well. The study includes collection of cytokines samples. The end-of-treatment visit and the last estimation of variable scores will occur at week 13 (visit 5) for all subjects. The final visit will be at week 15 (visit 6). Subjects will be encouraged to complete all planned visits regardless of their adherence to study drug administration.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis. Subjects with diagnosis of atopic dermatitis, using the Hanifin and Rajka Diagnostic Criteria, who meet inclusion/exclusion criteria will be randomized into 3 groups:

  1. Antroquinonol 100 mg PO QD
  2. Antroquinonol 50 mg PO QD
  3. Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Antroquinonol
    Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
    Other Name: Hocena
  • Other: Placebo
    The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects
Study Arms  ICMJE
  • Experimental: Antroquinonol 100 mg PO QD
    Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol,once a day.
    Intervention: Drug: Antroquinonol
  • Experimental: Antroquinonol 50 mg PO QD
    Antroquinonol (Hocena) 50mg/capsule. 1 capsules antroquinonol and 1 capsule placebo, once a day.
    Interventions:
    • Drug: Antroquinonol
    • Other: Placebo
  • Placebo Comparator: Placebo
    Placebo capsule, 2 capsules placebo, once a day
    Intervention: Other: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2019)
14
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
60
Actual Study Completion Date  ICMJE July 9, 2019
Actual Primary Completion Date July 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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, singing informed consent
  • To be eligible to participate, patients were required to havea.

    1. score of at least 5 on the Eczema Area and Severity Index (EASI), which rangesfrom 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:

  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 reatment 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 breast feeding
  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 NCT03622463
Other Study ID Numbers  ICMJE GHADERM-2-001
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Golden Biotechnology Corporation
Study Sponsor  ICMJE Golden Biotechnology Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheng-Chung Wei, MD Chung Shan Medical University
PRS Account Golden Biotechnology Corporation
Verification Date August 2019

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