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A Trial of Antroquinonol in Patients With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Antroquinonol
Placebo
Sponsored by
Golden Biotechnology Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Antroquinonol, Hocena

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chung Shan Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Antroquinonol 100 mg PO QD

Antroquinonol 50 mg PO QD

Placebo

Arm Description

Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol,once a day.

Antroquinonol (Hocena) 50mg/capsule. 1 capsules antroquinonol and 1 capsule placebo, once a day.

Placebo capsule, 2 capsules placebo, once a day

Outcomes

Primary Outcome Measures

EASI value
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

Secondary Outcome Measures

SCORAD
Scoring Atopic Dermatitis which ranges from 0 to 103, with higher scores indicating more severe disease

Full Information

First Posted
August 3, 2018
Last Updated
August 27, 2019
Sponsor
Golden Biotechnology Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03622463
Brief Title
A Trial of Antroquinonol in Patients With Atopic Dermatitis
Official Title
A Randomized, Double-Blind, Placebo-controlled Trial of Antroquinonol in Patients With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Golden Biotechnology Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Antroquinonol, Hocena

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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: Antroquinonol 100 mg PO QD Antroquinonol 50 mg PO QD Placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antroquinonol 100 mg PO QD
Arm Type
Experimental
Arm Description
Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol,once a day.
Arm Title
Antroquinonol 50 mg PO QD
Arm Type
Experimental
Arm Description
Antroquinonol (Hocena) 50mg/capsule. 1 capsules antroquinonol and 1 capsule placebo, once a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, 2 capsules placebo, once a day
Intervention Type
Drug
Intervention Name(s)
Antroquinonol
Other Intervention Name(s)
Hocena
Intervention Description
Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects
Primary Outcome Measure Information:
Title
EASI value
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
SCORAD
Description
Scoring Atopic Dermatitis which ranges from 0 to 103, with higher scores indicating more severe disease
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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; 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% Exclusion Criteria: 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 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 reatment 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 breast feeding 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Chung Wei, MD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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A Trial of Antroquinonol in Patients With Atopic Dermatitis

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