Chronic moderate or severe atopic dermatitis
Conditions
Interventions
Product Name: Cis-UCA 2.5% emulsion cream
Product Code: No product code available
Pharmaceutical Form: Cream
CAS Number: 7699-35-6
Current Sponsor code: cis-UCA
Other descriptive name: cis-urocanic ac
Sponsors
BioCis Pharma Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained prior to any screening procedure 2. Caucasian male or female patient 3. At least 18 years of age 4. Weight at least 45 kg 5. Patient with moderate or severe chronic atopic dermatitis 6. Good general health ascertained by medical history, physical examination and laboratory determinations, showing no signs of clinically significant findings, except chronic atopic dermatitis 7. Negative pregnancy test (premenopausal female patient) at screening and use of adequate contraceptive measures (both male and female patients) throughout the study and 30 days after the last cis-UCA dose - Premenopausal female patient 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) - Patient 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 a female participant, nor pregnancy test - Reliable contraception for a male patient is concordant with above listed methods for females, as applicable 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) yes 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 moderate or severe atopic dermatitis, that would interfere with the trial assessments or compromise the patient’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 dermatitis within one month (30 days) 4. Current use of active topical medication in the planned investigational area for chronic atopic dermatitis within two weeks (14 days) 5. History of a sunny holiday, UV-light therapy or solarium use within one month (30 days) before beginning of study treatments, or planning such during the study or within seven (7) days after the study 6. Allergy to cis-UCA, or any constituents of the placebo emulsion cream (decyl oleate, cetearyl alcohol, glycerine, sodium cetearyl sulfate and methylparaben) or any constituents of Protopic® ointment (white soft paraffin, liquid paraffinpropylene carbonate, white beeswax, hard paraffin) 7.History of any skin-related cancer 8. Congenital or acquired immunodeficiency or ongoing therapy that cause immunosuppression 9. Earlier participation in a clinical study performed with cis-UCA 10. Any clinically significant laboratory test result 11. Suspected current drug or alcohol abuse 12. Clinically significant illness during the 4 weeks prior to the first dose administration (as determined by the Investigator) 13. 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 patient 14. Unwillingness or doubtful capacity to comply with the protocol 15. Doubtful availability, in the opinion of the Investigator, to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the efficacy of two different doses of cis-UCA (2.5% and 5%) with placebo for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis to determine the dose of cis-UCA for further clinical development;Secondary Objective: - To evaluate safety and tolerability of cis-UCA after topical twice daily doses of 2.5% and 5% for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis. - To evaluate dose response after topical twice daily doses of 2.5% and 5% for up to 28 days in adult subjects with moderate or severe chronic atopic dermatitis. - To compare the efficacy and safety of 2.5% and 5% of cis-UCA to the efficacy and safety of 0.1% Protopic® after topical twice daily doses for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis ;Primary end point(s): The efficacy will be evaluated after treatment with cis-urocanic acid, placebo or comparator by Clinical Skin Assessment of erythema, oedema/papulation, oozing/crusts, excoriations, and lichenification at treatment area. Visual Analogue Scale assessment for itching (pruritus) of the treatment area will be also performed. In addition, the evaluation of the atopic eczema in the treatment area will be assessed by Physician Global Assessment, and measuring Skin Erythema and Transepidermal Water Loss at treatment area by specific non-invasive devices. The safety and tolerabilityof cis-urocanic acid will be evaluated by collecting adverse events. | — |
Countries
Finland
Outcome results
None listed