Mild to moderate plaque psoriasis
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. History of mild to moderate psoriasis of at least 12 months 5. Subjects with mild (a) or moderate (b) plaque psoriasis with the following diagnostic features: a. Mild to moderate psoriasis: i. Good control of lesions with topical therapy alone ii. BSA involvement of psoriatic lesions 10% or PASI =10. iii. Category moderate on PGA 6. Symmetric psoriatic lesions with the total area of approximately 75 cm2 (± 25 cm2) identifiable on both sides of the body (either on trunk, or upper or lower extremities). Preferable one psoriatic lesion to be treated at each side will be selected, but the total treatment area may consist of several separate lesions on either side (with symmetric appearance on sides). If the demand of area (75 cm2 ± 25 cm2 per side) is fulfilled with one lesion per side, no other lesions will be employed. 7. General medical condition according to the opinion of the Investigator does not interfere with the assessments and the completion of the trial 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 o 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) o Subjects with no current heterosexual relationship may be included according to the judgment of the Investigator o If menopause occurred 2 years ago at the minimum, no contraception is required for female participants, nor pregnancy tests o Reliable contraception for male subjects is concordant with above listed methods for females, as applicable 9. Body weight 60-120 kg for males and 50-100 kg for females; body mass index (BMI) 18-35 kg/m2 10. Laboratory determinations and ECG-recordings do not show signs of clinically relevant findings 11. No clinically relevant findings in vital signs [blood pressure (BP) or heart rate (HR)] 12. Ability to refrain from smoking when confined at the study site (up to appr. 9 h) 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 plaque psoriasis, 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 plaque psoriasis, that could compromise 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 plaque psoriasis, or other systemic medication with possible antipsoriatic activity (such as methotrexate, cyclosporine or other immunosuppressants, corticosteroids, or retinoids) within 30 days before the first treatment 4. Current use of active topical medication (such as corticosteroids and Vitamin D derivatives) on the psoriatic lesions to be treated in this study within 30 days before the first treatment. Basic creams are allowed on all lesions until the first treatment. 5. History of a sunny holiday, solarium use, or phototherapy within one month (30 days) before starting the study treatments, or planning such during the study or within 30 days after the study 6. Tattoos at the selected lesions 7. Secondary changes of psoriatic lesions (e.g., acute eczema or bacterial infection), severe symptoms of skin irritation or any other changes, that would prevent the evaluation of the treatment effect at the index lesions, according to Investigator’s judgment 8. Allergy to cis-UCA, or any constituents of Aqualan® (decyl oleate, cetearyl alcohol, glycerine, sodium cetearyl sulphate and methylparaben) 9. History of any cancer or current cancer 10. Earlier participation in a clinical study performed with cis-UCA 11. 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 12. Any medical condition (such as renal impairment) which might significantly alter the absorption, distribution or excretion of cis-UCA 13. Any clinically significant laboratory test result (including positive tests for HIV and hepatitis B or C) 14. 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) 15. Suspected current use of illicit drugs (medical history, physical examination, screening laboratory determinations) 16. Clinically significant illness during the 4 weeks prior to the first dose administration (as determined by the Investigator) 17. 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 18. Unwillingness or doubtful capacity to comply with the protocol 19. Doubtful availability, in the opinion of the Investigator, to complete the study 20.Poor peripheral venous access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate pharmacokinetics of 5% cis-UCA emulsion cream after topical twice daily doses for up to 28 days in adult subjects with mild to moderate plaque psoriasis;Secondary Objective: - To evaluate safety and tolerability of 5% cis-UCA emulsion cream after topical twice daily doses for up to 28 days in adult subjects with mild to moderate plaque psoriasis - To obtain preliminary information on the efficacy of 5% cis-UCA emulsion cream after topical twice daily doses for up to 28 days in adult subjects with mild to moderate plaque psoriasis ;Primary end point(s): 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 will be evaluated by collecting adverse events, with particular emphasis on skin-related adverse events, and by performing Visual Severity Scoring (VSS) on the healthy skin surrounding the treated lesions. The efficacy of cis-urocanic acid on mild to moderate plaque psoriasis will be evaluated by assessing and measuring Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), Visual Assessment of Index Lesions (VAIL), and Transepidermal Water Loss (TEWL) at the treated skin leasions. | — |
Countries
Finland
Outcome results
None listed