atopic eczema
Conditions
Interventions
Product Name: SB011
Pharmaceutical Form: Cutaneous emulsion
Other descriptive name: hgd40
Concentration unit: % percent
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the pl
Sponsors
sterna biologicals GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a patient in this trial: 1. Patient has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure; 2. Adult Caucasian patients (male and female) aged 18-69 years (both included); 3. Patients smoking = 10 cigarettes/day; 4. Patient has confirmed diagnosis of atopic dermatitis using the diagnostic features as described by Hanifin and Rajka (6), initial diagnosis made at least 12 weeks before first treatment; 5. SCORAD (12) between 20 and 50 (mild to moderate atopic dermatitis); 6. 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; 7. Patient has to have an increased total IgE; 8. Patient has to have an increased specific IgE of at least 1 of the sx1 allergens with CAP classification II [>0.7 KU/l]; 9. Erythema score from modified local SCORAD for both lesional areas of at least 2; 10. 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); 11. 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; 12. The male patient must agree: - to use two methods of contraception in combination with his female partner, if she is of childbearing potential; this combination of contraceptive methods must be used from screening until at least 6 months after the last dose of IMP. At least one of the contraception methods must be a barrier contraception method. Contraceptive methods allowed include the following: condoms, as well as for female partner’s diaphragm in combination with a spermicide, intrauterine device, oral contraception, contraception implants, OR - not to be sexually active at screening and accept using double-barrier contraception should he become sexually active during the trial or within 6 months after the last dose of IMP, OR - to have been surgically sterilised prior to screening and accept to use a barrier method of contraception as well, OR - to have a partner who is post-menopausal and has had her last natural menstruation at least 12 months prior to screening, OR - to have a partner who has had a hysterectomy prior to screening, OR - to have a partner who has been surgically sterilised prior to screening; 13. The female patient must agree: - to use two methods of contraception in combination with her male partner, if she is of childbearing potential; this combination of contraceptive methods must be used from screening until at least 6 months after the last dose of IMP. At least one of the contraception methods must be a barrier contraception method. Contraceptive methods allowed include the following: condoms, as well as for female partner’s diaphragm in combination with a spermicide, intrauterine device, or
Exclusion criteria
Exclusion criteria: Patients are to be excluded from the trial, when one or more of the following conditions are met: 1. History of allergic reactions to any active or inactive component of the IMP; 2. 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, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the trial or the patient’s ability to take part in it; 3. Inherent or acquired immune deficiency, immune deficiency in consequence of drug use; 4. Immune mediated diseases; 5. Suntan, hyperpigmentation or tattoos in the test fields; 6. Dark-skinned persons whose skin colour prevents ready assessment of skin reactions; 7. Systemic bacterial or mycotic as well as severe viral systemic infections; 8. Severe systemic other disease; 9. Patients with a resting heart rate 100 bpm, systolic blood pressure 150 mmHg, diastolic blood pressure 95 mmHg, on condition that the patient does not present any clinical symptoms of hypotension; 10. UV-therapy within 6 weeks before first treatment and during the trial; 11. 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); 12. Clinically relevant abnormalities in serology, clinical chemical, haematological or in any other laboratory variables; 13. Chronic or acute infections (a small lesion of non-treated onychomycosis will be allowed in the opinion of the investigator); 14. Pregnancy or nursing 15. Signs of secondary infections on the lesions to be treated; 16. History of previous administration of SB011 or any other registered or investigational oligonucleotide-based drug; 17. History or presence of alcohol or drug abuse; 18. Consumption of alcohol within 48 h before administration of IMPs and during the trial; 19. 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); 20. 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; 21. Consumption of grapefruit, grapefruit juice within 14 days prior to the IMP administration or during the trial; 22. Need for additional skin care products in the treatment area(s); 23. 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; 24. Proneness to orthostatic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate efficacy of the topical formulation SB011 containing 2 % hgd40 on lesional skin by clinical assessment of skin condition in patients with mild to moderate atopic eczema ;Secondary Objective: The secondary objective is to evaluate the safety, tolerability and pharmacokinetic profile of the topical formulation SB011 containing 2 % hgd40 in patients with mild to moderate atopic eczema;Primary end point(s): Primary enpoint is comparison of active IMP vs. vehicle with respect to the change from baseline in modified local SCORAD on Day 15.;Timepoint(s) of evaluation of this end point: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective of this trial is to evaluate the safety, tolerability and pharmacokinetic profile of the topical formulation SB011 containing 2 % hgd40 in patients with mild to moderate atopic eczema;Timepoint(s) of evaluation of this end point: complete Treatment period | — |
Countries
Germany
Contacts
Public ContactClinical Trial Manager
bioskin GmbH
Outcome results
None listed