A study to see the effects of Zileuton ointment in patients with moderate to severe atopic dermatitis

Phase 2

Conditions: Health Condition 1: L209- Atopic dermatitis, unspecified

Registration Number: CTRI/2019/12/022212

Lead Sponsor: Dr Srinivas Sidgiddi MD Director Clinical Development

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Subject understands the study procedures, is willing to comply with the study procedures and required visits and agrees to participate by giving written informed consent. Subjects with a legal guardian, must have the written informed consent of the legal guardian

2. Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study

3. Male and female subjects aged 18 years to 75 years

4.Subjects must be diagnosed with Atopic Dermatitis (AD) as per revised Hanifin and Rajka criteria

5. Subjects must have IGA grade of â??Moderate (3)â?? to â??Severe (4)â?? at Baseline

6. Subjects must have AD lesions affecting <=20% of the body surface area (BSA) at Baseline (subjects will be instructed to avoid applying IP around eyes, mouth and nostrils).

7. Willing to provide skin biopsy of the target lesion at Baseline and end of treatment visits

8. Female subjects of childbearing potential in addition to having a negative urine pregnancy test, must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive),

9. throughout the study. If the female is using a hormonal contraceptive, the same product must be taken for 3 months prior to study treatment and must agree not to replace with some other hormonal contraceptives during the study.

A female is considered of childbearing potential unless she is:

i. pre-menarche

ii. postmenopausal for at least 12 months prior to IP administration

iii.without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 6 months prior to IP administration

10. Subjects must be able to have >= 28 days washout from the following prohibited medications:

i. Oral or Intravenous corticosteroids (nasal and inhaled steroids are allowable)

ii. Any biological therapy (including intravenous immunoglobulins)

iii. UVA/UVB therapy

iv. PUVA (psoralen plus ultraviolet A) therapy

v. Systemic cytotoxic or immunosuppressive drugs (e.g. Methotrexate, Azathioprine, Cyclosporine etc.)

vi. Topical and Systemic Immunomodulators (e.g. Tacrolimus, Sirolimus, Pimecrolimus, Mycophenolate mofetil, Imiquimod etc.)

vii. Systemic, topical or intralesional interferon

11. Subjects must be able to have >= 14 days washout from the following prohibited medications:

i. Systemic antibiotics and anti-fungals

ii. Calcipotriene or other vitamin D preparations

iii. Retinoids (oral and topical)

iv. Topical corticosteroids (for skin)

12. Subjects must be able to have >= 7 days washout from the following prohibited medications:

i. Topical or systemic antihistamines

ii. Systemic leukotriene inhibitors (montelukast)

iii.Topical or systemic NSAID (however daily low-dose aspirin is allowed, as long as the subject has been on a stable dose, <= 100 mg once a day, for 60 days prior to the start of the study; subjects may use acetaminophen/paracetamol as required)

iv. Topical antibiotics

v. Other topical drug products

13. Subjects must agree not to use any product on the treatment area during the entire course of study except the products advised by the Investiga

Exclusion Criteria

1. Known or suspected hypersensitivity to zileuton or any component of the formulation of the study medication

2. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations

3. History or presence of other skin conditions, e.g., scabies, psoriasis, rosacea, erythroderma, ichthyosis that may either confound the diagnosis of AD or interfere with the assessment of study endpoints

4. History or presence of Nethertonâ??s Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection

5. Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease

6. Serum ALT and/or AST >= 3 times ULN at screening

7. Significant history (within the past year) of alcohol or drug abuse

8. Unstable AD or any consistent requirement for high potency topical corticosteroids as judged by the Investigator

9. Current use of biologic therapy

10. Participation in any clinical research study within 30 days of the Baseline Visit

11. Concomitant use of cosmetics or other topical drug products on or near the selected treatment area, except the products advised by the Investigator

12.Anticipated concurrent requirement for treatment with propranolol, warfarin and theophylline

13.Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within 4 weeks and within 2 cm of the selected treatment area

14. Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit

15. Females who are pregnant or lactating or planning to become pregnant during the study period

Subjects who are unable to comply with the study requirements for any reason

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IGA treatment â??successâ??, i.e., clear or almost clear; a score of 0 or 1, with at least a two- grade reductionTimepoint: Baseline to Week 4

Secondary Outcome Measures

Name	Time	Method
IGA treatment â??successâ??, i.e., clear or almost clear; a score of 0 or 1, with at least a two-grade reductionTimepoint: Baseline to Week 4;Least a two-grade improvement of IGA gradeTimepoint: Baseline to Week 4;Mean change in SCORADTimepoint: Baseline to Week 4;Mean change in the BSA involvedTimepoint: Baseline to Weeks 1, 2 and 4;Mean change in the EASI scoreTimepoint: Baseline to Weeks 1, 2 and 4