Clinical trial: Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of the Topical Formulation SB011 Applied to Lesional Skin in Patients With Atopic Eczema (NCT02079688)

Eligibility criteria:
Inclusion Criteria:

          -  Patient oral and written informed consent

          -  Adult Caucasian patients (male and female) aged 18-69 years (both included);

          -  Patients smoking ≤ 10 cigarettes/day

          -  Patient has confirmed diagnosis of atopic dermatitis using the diagnostic features as
             described by Hanifin and Rajka, initial diagnosis made at least 12 weeks before first
             treatment;

          -  SCORAD (12) between 20 and 50 (mild to moderate atopic dermatitis);

          -  Two comparable lesional areas of approximately 50 cm2 each (difference in modified
             local SCORAD not greater than 2) on the arms, legs, chest, stomach or neck (distance
             between the lesions at least 5 cm), clinical condition of atopic eczema mild to
             moderate defined by a modified local SCORAD between 7 and 10 with 2 parameters scored
             at least 2 one being the erythema score;

          -  Patient has to have an increased total IgE;

          -  Patient has to have an increased specific IgE of at least 1 of the sx1 allergens with
             CAP classification II [>0.7 KU/l];

          -  Erythema score from modified local SCORAD for both lesional areas of at least 2;

          -  TEWL in the lesional areas at least 12 g/m²h, TEWL value differences ≤ 30 % are
             allowed between both lesional areas (related to the higher TEWL value);

          -  Except for atopic diseases or asthma like atopic dermatitis or allergic rhinitis
             assessed as healthy based on a screening examination including medical history,
             physical examination of the skin, vital signs, and clinical laboratory results;

          -  The male patient must agree:

          -  to use two methods of contraception in combination with his female partner, if she is
             of childbearing potential (At least one of the contraception methods must be a barrier
             contraception method)

          -  The female patient must agree:

          -  to use two methods of contraception in combination with her male partner, if she is of
             childbearing potential;

        Exclusion Criteria:

          -  History of allergic reactions to any active or inactive component of the IMP;

          -  Presence of clinically significant diseases other than asthma or atopic diseases
             (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological,
             genitourinary, autoimmune, endocrine, metabolic, etc.) which in the opinion of the
             investigator, influence the results of the trial or the patient's ability to take part
             in it;

          -  Inherent or acquired immune deficiency, immune deficiency in consequence of drug use;

          -  Immune mediated diseases;

          -  Suntan, hyperpigmentation or tattoos in the test fields;

          -  Dark-skinned persons whose skin colour prevents ready assessment of skin reactions;

          -  Systemic bacterial or mycotic as well as severe viral systemic infections;

          -  Severe systemic other disease;

          -  Patients with a resting heart rate <50 and >100 bpm, systolic blood pressure <100 and
             >150 mmHg, diastolic blood pressure <60 and >95 mmHg;

          -  UV-therapy within 6 weeks before first treatment and during the trial;

          -  History or current evidence of a malignant tumour (an excised basal cell carcinoma
             distant from target lesion with at least 14 days after surgery will be allowed);

          -  Clinically relevant abnormalities in serology, clinical chemical, haematological or in
             any other laboratory variables;

          -  Chronic or acute infections (a small lesion of non-treated onychomycosis will be
             allowed in the opinion of the investigator);

          -  Pregnancy or nursing

          -  Signs of secondary infections on the lesions to be treated;

          -  History of previous administration of SB011 or any other registered or investigational
             oligonucleotide-based drug;

          -  History or presence of alcohol or drug abuse;

          -  Consumption of alcohol within 48 h before administration of IMPs and during the trial;

          -  Use of any medication (including over-the-counter medication such as herbal products)
             except allowed concomitant medication within 2 weeks (for biologics: 6 months, for
             systemic treatment of atopic dermatitis 4 weeks) before administration of the IMPs or
             within <10 times the elimination half-life of the respective drug, or the duration of
             the pharmacodynamics effect, whatever is longer, or anticipated concomitant medication
             during the treatment period (exception: asthma may be found in patients with AD,
             therefore the continuation of inhalative treatment with corticosteroids in patients
             with asthma accompanying AD that began at least four weeks prior to randomisation will
             be allowed; dose limited: ≤ 300 μg/d fluticasone propionate or equivalent);

          -  Treatment with known cytochrome P450 enzyme inducing or inhibiting agents (St. John's
             Wort ("Johanniskraut"), barbiturates, phenothiazines, cimetidine, ketoconazole) within
             30 days before administration of the IMPs or during the trial;

          -  Consumption of grapefruit, grapefruit juice within 14 days prior to the IMP
             administration or during the trial;

          -  Need for additional skin care products in the treatment area(s);

          -  Use of skin care products with anti-septic components during the last four weeks
             before first treatment and during the trial or anti-septic textiles with contact to
             the target lesions;

          -  Proneness to orthostatic dysregulation, faintings, or blackouts;

          -  Planned donation of germ cells, blood, organs, bone marrow during the course of the
             trial or within 6 months thereafter;

          -  Participation in another clinical trial with an investigational drug or device within
             the last 3 months. For biologics, the minimum exclusion period is at least 6 months or
             the time of duration of the pharmacodynamics effect or 10 times the half-life of the
             respective drug whatever is longer before inclusion in this trial;

          -  Lack of ability or willingness to give informed consent;

          -  Anticipated non-availability for trial visits/procedures;

          -  Anticipated lack of willingness or inability to cooperate adequately;

          -  Close affiliation with the investigators (e.g. a close relative) or with persons
             working at bioskin GmbH or with persons working at the study site or with employees of
             sterna biologicals GmbH & Co. KG;

          -  Vulnerable patients (e.g., persons kept in detention)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 69 Years

Patient description (medical language): A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago.  A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy.  The patient has had a few upper respiratory infections but no major illnesses.  Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance.  Vital signs and milestone examination are within normal limits.  Similar findings are observed on the cheeks and proximal upper extremities.  The diaper area is clear, and no mucosal lesions are present.

Patient description (patient's own words): I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions.

Does the patient match the trial criteria? Contradiction