Safety, Tolerability and Efficacy of ZEP-3Na (0.1% or 1%) Compared to Placebo in Subjects With Mild to Moderate Atopic Dermatitis

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, double blind study with ZEP-3NA 0.1% or 1% vs. vehicle-control in subjects with mild to moderate Atopic Dermatitis. The IP (Investigational Product) will be administered topically twice daily for 12 weeks.

The purpose of this study is to assess the safety, tolerability and efficacy of two concentrations of ZEP-3NA compared to vehicle-control.

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

Details

• Lead Sponsor: Shulov Innovate for Science Ltd. 2012

Criteria

Inclusion Criteria:

1. Male or female 5 to 75 years old, inclusive.

2. Clinical diagnosis of Atopic Dermatitis (as defined by Hanifin and Rajka criteria).

3. Atopic Dermatitis should be present for at least three months with stable disease for ≥ 1 month prior to screening.

4. IGA score of 2 or 3 (mild or moderate) during screening and baseline.

5. Women of child bearing potential must have a negative urine pregnancy test at screening and use an adequate contraceptive method throughout the study. Males with partners of childbearing potential should inform them of their participation in this clinical study and use an adequate contraceptive method throughout the study.

6. Willing and able to comply with study instructions and commit to attending all visits.

7. The patient/parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form prior to performing any study-related procedure. Children 7-17 years old should be willing and able to sign Assent Form.

Exclusion Criteria:

1. Unstable or actively infected atopic dermatitis.

2. Concomitant dermatologic (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to study drug.

3. Patients with Atopic Dermatitis affecting only the scalp will be excluded from the study. In addition, patients with the scalp representing ≥ 25% of the affected area will be excluded as well.

4. Has received treatment two weeks prior to visit 2 with topical corticosteroids or four weeks prior to visit 2 with systemic immunosuppressive drugs and/or corticosteroids or plans to receive treatment during the study timeframe with immunosuppressive drugs and/or corticosteroids (topical or systemic).

5. Subjects who are using any concomitant medications that, in the investigator's opinion, could affect the subject's atopic dermatitis (e.g Antihistamines). Subjects using such medications and have been stable on treatment for at least one month prior to study entry and no changes to these medications are planned during study, may be included in the study, at the investigator's discretion.

6. Subject had UVA or UVB therapy in the last two weeks or is due to have it during the study period.

7. Any vaccination in the last 30 days prior to the screening visit.

8. Abnormal renal function (defined as serum creatinine >1.5xULN).

9. Abnormal liver function (defined as any transaminases >2xULN).

10. Clinically significant abnormalities as determined by the Investigator on the 12-lead ECG conducted at the screening visit (for adults only).

11. Subject has active or history of malignancy, except non melanomatous skin cancer cured by excision. Subjects with past malignancy who had completed therapy and are free of the disease for at least 5 years may be included in the study, at the investigator's discretion.

12. History of immunodeficiency syndrome (e.g. atypical rash morphology, FTT, serve bacterial, fungal or viral skin infections, etc).

13. Subjects who are receiving any investigational drug or who participated in a clinical trial with an investigational product within the last 30 days or 5-half-lives of the investigational product, whichever is longer.

14. History of any anaphylactic reaction or history or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis and atopic dermatitis).

15. Known hypersensitivity to any of the components of the study drug.

16. Known or suspected history of alcohol or drug abuse.

17. Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history.

18. Pregnant or lactating women.

19. Any history which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.