A Trial of Antroquinonol in Patients With Atopic Dermatitis

NCT03622463 | Completed Phase 2

• 1 other identifier: GHADERM-2-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Antroquinonol; Hocena

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (1)

• SCORAD

  12 weeks

Study Arms (3)

Antroquinonol 100 mg PO QD

EXPERIMENTAL

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

Drug: Antroquinonol

Antroquinonol 50 mg PO QD

EXPERIMENTAL

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

Drug: Antroquinonol; Other: Placebo

Placebo

PLACEBO COMPARATOR

Placebo capsule, 2 capsules placebo, once a day

Other: Placebo

Interventions

Antroquinonol DRUG

Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.

Also known as: Hocena

Antroquinonol 100 mg PO QD; Antroquinonol 50 mg PO QD

Placebo OTHER

The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects

Antroquinonol 50 mg PO QD; Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Golden Biotechnology Corporation: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

antroquinonol

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Cheng-Chung Wei, MD

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 9, 2018
• Study Start: July 17, 2018
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)