Chronic mild to moderate atopic dermatitis
Conditions
Sponsors
BioCis Pharma Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained prior to any screening procedures 2. White skinned male or female subjects 3. Age between 18-65 years of age 4. Subjects with chronic mild to moderate atopic dermatitis with the following diagnostic features: - History within 12 months of itching dermatitis in one or several of localizations typical of atopic dermatitis (antecubital/cubital fossae; face/neck/upper trunk; volar aspects upper extremities / thighs). - Objective signs of mild or moderate eczema OR dry skin in one or several of above mentioned locations 5. No current treatment with active medication for atopic dermatitis 6. Symmetric presentation of atopic dermatitis in the volar forearms to allow randomization of the treatments 7. Good general health ascertained by medical history, physical examination, ECG-recording and laboratory determinations, showing no signs of clinically significant findings, except chronic atopic dermatitis 8. Negative pregnancy test (premenopausal female subjects) at screening and use of adequate contraceptive measures (both male and female subjects) throughout the study and 30 days after the last cis-UCA dose - Premenopausal female volunteers should be either surgically sterile or using a reliable contraception method: intrauterine device (hormonal or non-hormonal); oral combination pill or hormonal contraception patch; or two of the following: intra-vaginal hormonal ring, oral contraceptive containing progestin only, spermicidal foam, condom, sterilization of male sexual partner (surgical vasectomy) - Subjects with no current heterosexual relationship may be included according to the judgment of the Investigator - If menopause occurred 2 years ago at the minimum, no contraception is required for female participants, nor pregnancy tests - Reliable contraception for male subjects is concordant with above listed methods for females, as applicable 9. Body weight 60-100 kg for males and 45 -85 kg for females; body mass index (BMI) 18-30 kg/m2 10. Supine blood pressure (BP) after 3 minutes rest: systolic 100-150 mmHg, diastolic 60-90 mmHg, and supine heart rate (HR) after at least 3 minutes rest: 40-90 beats per minute 11. Non-smoker and not using any nicotine products Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of other significant skin disease (e.g. any skin disease requiring hospitalization), or skin manifestations of allergic illness or other dermatologic condition, except chronic mild to moderate atopic dermatitis, that would interfere with the trial assessments or compromise the subject’s safety according to the opinion of the Investigator 2. Present symptoms of other skin diseases, except chronic atopic dermatitis, that could disturb the study assessment and evaluation of the skin, according to the opinion of the Investigator 3. Current use of any active systemic medication (i.e. oral, subcutaneous, intravenous) for chronic atopic dermatis within one month (30 days) 4. Current use of active topical medication in the investigational area for chronic atopic dermatis within one month (30 days) 5. History of a sunny holiday or solarium use within one month (30 days) before beginning of study treatments, or planning such during the study or within 30 days after the study 6. Asymmetric presentation or only single lesion of atopic dermatitis on volar forearms 7. Tattoos on the volar side of either forearm 8. Damaged skin at the test site (e.g. uneven skin pigmentation, numerous freckles, scars or other disfigurations) or clinical signs or symptoms of skin irritation (e.g. pruritus, burning, erythema) 9. Allergy to cis-UCA, or any constituents of Aqualan® (decyl oleate, cetearyl alcohol, glycerine, sodium cetearyl sulphate and methylparaben) 10. History of any cancer or current cancer 11. Earlier participation in a clinical study performed with cis-UCA 12. Use of prescription drugs within 14 days prior to dosing or over the counter medication within 7 days prior to dosing. Paracetamol is allowed for occasional pain. Antihistamine is allowed for allergic symptoms. Non-cortisone nasal sprays and eye drops are also allowed. 13. Donation of blood or participation in another drug study within 60 days (males) or 90 days (females) before the first product administration in this study 14. Any medical condition (such as renal impairment) which might significantly alter the absorption, distribution or excretion of cis-UCA 15. Any clinically significant laboratory test result (including positive tests for HIV and hepatitis B or C) 16. Excessive use of alcohol (on average more than 24 units per week for males, and more that 16 units per weeks for females; unit = 4 cl spirits or equivalent) 17. Suspected current use of illicit drugs (medical history, physical examination, screening laboratory determinations) 18. Clinically significant illness during the 4 weeks prior to the first dose administration (as determined by the Investigator) 19. Any other condition that in the opinion of the Investigator would interfere with the evaluation of the study results or constitute a health hazard for the subject 20. Unwillingness or doubtful capacity to comply with the protocol 21. Doubtful availability, in the opinion of the Investigator, to complete the study 22. Poor peripheral venous access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate pharmacokinetics of cis-UCA after topical twice daily doses for 10 days in adult subjects with mild to moderate atopic dermatitis ;Secondary Objective: - To evaluate safety and tolerability of cis-UCA after topical twice daily doses for up to 28 days in adult subjects with mild to moderate atopic dermatitis - To obtain preliminary information on the efficacy of cis-UCA after topical twice daily doses for up to 28 days in adult subjects with mild to moderate atopic dermatitis ;Primary end point(s): The pharmacokinetic parameters will be determined from the concentration-time data of plasma and urine cis-urocanic acid. The safety and tolerability of cis-urocanic acid after repeated topical doses up to 28 days will be evaluated by collecting adverse events and assessing visual skin reaction severity scoring for erythema, skin swelling, formation of papules, formation of vesicles or bullaes, and scaling. The efficacy of cis-urocanic acid on mild to moderate atopic dermatitis will be assessed by evaluating skin erythema, transepidermal water loss, Physician's Global Assessment (PGA), and the total body Ezcema Area Severity Index (EASI). | — |
Countries
Finland
Outcome results
None listed