Protocol 271-12-205: A Phase 2 Multi-center, Randomized, Double-blind, Vehicle-controlled, Three-arm, Parallel Group Study to Assess the Safety, Tolerability, and Efficacy of Topical OPA-15406 Ointment, in Subjects With Mild/Moderate Atopic Dermatitis
- Conditions
- Mild/Moderate Atopic Dermatitis (AD)Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]MedDRA version: 17.1Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 17.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 17.1Level: HLGTClassification code 10014982Term: Epidermal and dermal conditionsSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
- Registration Number
- EUCTR2013-003899-12-PL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1.The ability to provide written informed consent by parent/guardian or a legal representative (as required by local regulations) prior to the commencement of study procedures, and the ability to comply with all study requirements as assessed by the principal investigator. Additionally, a patient must provide informed consent during the screening and be able to understand that he/she may withdraw from the study at any time. All procedures for obtaining informed consent must comply with the legal requirements of an independent review board/ independent bioethics committee (IRB/IEC) of the site and local regulations. The inclusion of minors requires that parents or guardians of a minor participant are given information and provide written informed consent. If a patient participating in the study will have become 18 years (or the age of majority as specified by local laws and regulations) within 4 weeks prior to entering study 271 12-205 or in the course of the study, the informed consent should be obtained from him/her.
2.Men and women aged 10 to 70 years (inclusive).
3.Diagnosis of atopic dermatitis based on the Hanifin and Rajka criteria
4.History of atopic dermatitis for at least 3 years and/or documented diagnosis of atopic dermatitis by the investigator during the screening visit, if the patient has provided information on the 3-year history of the condition.
5.Atopic dermatitis covering = 5% to = 40% of the patient's total body surface area (BSA), except for face, neck and head, during the screening visit and the initial visit.
6.Score on the IGA disease severity scale of 2 (light) or 3 (moderate) in selected therapeutic areas during the screening visit and initial visit.
7.At least 1 measurable and assessable target change with the IGA score of 2 (light) or 3 (moderate).
8.Willingness to have photos taken of selected target changes in the course of the study.
9.Positive, though insufficient, response (previously documented or reported by the patient during a detailed screening interview), as assessed by the investigator, to at least one course of standard therapy, including: Topical steroids, UVA radiation, narrow-band UVB radiation, and UVB radiation or current inability to administer effective prior treatment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1.Women during pregnancy or breastfeeding
2.Sexually active men and women of reproductive age who do not use dual contraceptive method or sexual abstinence at the time of the study and for 8 weeks after the last dose of the investigational medicinal product (IMP).
3.Recurrence of contact or atopic dermatitis within 28 days before the initial visit (Day 1), defined as a sudden intensification of atopic dermatitis.
4.History of concomitant conditions or other diseases (e.g., acne, psoriasis etc.) of significant intensity in selected therapeutic areas that may impact assessments performed for the study.
5.Active acute viral skin infection (e.g., herpes, zoster, varicella) and/or atopic dermatitis with clinical infection.
6.History of malignant tumor or malignant tumor within the last 5 years (except for treated (i.e. cured) basal cell carcinoma or squamous cell skin cancer).
7.History of recurrent bacterial infection defined as 3 large infections leading to hospitalization and/or requiring intravenous antibiotic therapy in the last 2 years.
8.Clinically significant history or test results
9.Results of laboratory tests:
•Number of white blood cells =3,000/µl and >14,000/µl (<14 x 109/l),
•Platelets =100,000/µl (100 x 109/l),
•Haemoglobin<11 g/dL
•Serum Creatinine =2 mg/dL
•Aspartate aminotransferase >1.5 x GGN
•Alanine transaminase >1.5 x GGN
•Total bilirubin = 2.0 mg/dL
•or any other abnormal and, in the opinion of the investigator, clinically relevant, laboratory result
10.Clinically relevant results of 12-lead electrocardiogram (ECG), such as: AV block, elongation of the QRS complex greater than 120 ms or QTcF interval =450 ms.
11.Clinically relevant blood pressure or heart rate results, such as:
•Age 18-70 years (inclusive): Systolic blood pressure in the seated position (=3 minutes) <100 or =150 mmHg and/or diastolic blood pressure <50 mmHg or =90 mmHg and/or heart rate <50 or >100 beats/min.
•Age =17 years (inclusive): Systolic blood pressure in the seated position (=3 minutes) <95 or =140 mmHg and/or diastolic blood pressure <50 mmHg or =90 mmHg and/or heart rate <50 or >100 beats/min.
12.Use of systemic immunosuppressants/immunomodulators, corticosteroids, antimetabolites or retinoids within 28 days before the initial visit (Day 1) or plans to use them during the study. Intraocular, intranasal or inhalant corticosteroids may be considered if, in the opinion of the investigator, their use does not affect assessment of the therapeutic area or areas.
13.Use of local immunomodulators, group I -VII WHO classification corticosteroids, or retinoids on the body (i.e. below the neck) within 7 days before the initial visit (Day 1) or plans to use them during the study. Local application of weak corticosteroids may be considered if, in the opinion of the investigator, their use does not affect assessment of the therapeutic area or areas.
14.Phototherapy (UVA, narrow-band UVB radiation, and UVB radiation) within 28 days of the initial visit (Day 1) or reluctance to reduce exposure to sun rays, avoid sunbathing, tanning salons, and ultraviolet radiation therapy at the time of the study.
15.Use of systemic or local antihistamines within 7 days before the initial visit (Day 1) or plans to use them during the study. Intraocular, intranasal or inhalant antihistamines may be considered if, in the opinion of the investigator, their use does not affect assessment of the therapeutic area or areas.
16.Use of any systemic or local study medic
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method