A Trial of Antroquinonol in Patients With Atopic Dermatitis

• ClinicalTrials.gov Identifier: NCT03622463
• Recruitment Status: Completed
• First Posted: August 9, 2018
• Last Update Posted: August 29, 2019
• Sponsor: Golden Biotechnology Corporation
• Information provided by (Responsible Party): Golden Biotechnology Corporation

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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Antroquinonol; Other: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• 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
• Official Title: A Randomized, Double-Blind, Placebo-controlled Trial of Antroquinonol in Patients With Atopic Dermatitis
• Actual Study Start Date: July 17, 2018
• Actual Primary Completion Date: July 9, 2019
• Actual Study Completion Date: July 9, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Antroquinonol 100 mg PO QD; Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol,once a day.	Drug: Antroquinonol; Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.; Other Name: Hocena
Experimental: Antroquinonol 50 mg PO QD; Antroquinonol (Hocena) 50mg/capsule. 1 capsules antroquinonol and 1 capsule placebo, once a day.	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
Placebo Comparator: Placebo; Placebo capsule, 2 capsules placebo, once a day	Other: Placebo; The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. SCORAD [ Time Frame: 12 weeks ]
   Scoring Atopic Dermatitis which ranges from 0 to 103, with higher scores indicating more severe disease

Eligibility Criteria

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

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.

  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.

Contacts and Locations

Locations

Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Sponsors and Collaborators

Golden Biotechnology Corporation

Investigators

• Principal Investigator: Cheng-Chung Wei, MD; Chung Shan Medical University

More Information

• Responsible Party: Golden Biotechnology Corporation
• ClinicalTrials.gov Identifier: NCT03622463
• Other Study ID Numbers: GHADERM-2-001
• First Posted: August 9, 2018
• Last Update Posted: August 29, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Golden Biotechnology Corporation:

Antroquinonol; Hocena

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases