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

• Status: Terminated
• Trial end date: 2019-06-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chung Shan Medical University
• Collaborator: Golden Biotechnology Corporation
• Treatments: Ubiquinone

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.