Psoriasis vulgaris
Conditions
Interventions
Product Name: PAD™ calcipotriol cream
Product Code: MC2-01 (calcipotriol)
Pharmaceutical Form: Cream
INN or Proposed INN: CALCIPOTRIOL
CAS Number: 112828-00-9
Concentration unit: mg/g milligram(s)/gra
Sponsors
Drug Delivery Solutions Aps (DDS) c/o MC2 Biotek Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 years or above having signed and dated an informed consent, 2. Female subject of non-child bearing potential, defined as surgically sterile or post-menopausal (at least one year post cessation of menses), 3. Female of childbearing potential who has been, in the opinion of the Investigator, using an approved method of birth control (e.g. oral contraception pill or patch, intra-uterine devices, contraceptive implants or vaginal rings, condoms) for at least 1 month prior to Screening visit. Subject having a negative urine pregnancy test at screening and agreeing to continue adequate contraception during the entire study period and 1 month after the end of the study, 4. Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk. The subjects should have one or more plaques for the application of the six (6) products, 5. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at baseline visit, 6. Subjects with psoriasis lesions (plaques) which must have a sum of scores of erythema, scaling and infiltration = 5 and each individual item must be = 1, 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis, 2. Female subjects who are pregnant or who are breast feeding, 3. Subjects with systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 months prior to randomisation and during the study, 4. Subjects with any systemic treatments, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the study. 5. Subjects using any potent or very potent (WHO group III-IV) topical corticosteroids within the 4 week period prior to randomisation, 6. Subjects using of phototherapy within 4 weeks prior to randomisation: 7. Subjects using topical drugs for the treatment of psoriasis within two weeks prior to randomisation such as: - Topical retinoids (e.g. tazarotene), - Topical vitamin D analogues (e.g. calcipotriol), - Topical immunomodulators (e.g. macrolides), - WHO group I-II corticosteroids (except on facial psoriasis), 8. Subjects using emollients on the selected plaques within one week before randomisation and during the study, 9. Subjects with initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of a PAD Calcipotriol cream MC2-01 (calcipotriol) compared to two calcipotriol reference formulations (Daivonex® cream and calcipotriol ointment (Sandoz)) in patients with plaque psoriasis;Secondary Objective: The secondary objectives of this study are: ? - to compare the efficacy of: - the PAD™ calcipotriol cream MC2-01 (calcipotriol) versus its matching vehicle cream MC2-01 (vehicle), - the PAD™ calcipotriol/betamethasone cream MC2-01 (calcipotriol/BDP) versus Daivobet® ointment, - the PAD™ calcipotriol/betamethasone cream MC2-01 (calcipotriol/BDP) versus PAD™ calcipotriol cream (MC2-01 (calcipotriol) and to the cream MC2-01 (vehicle). ? - to evaluate the local skin tolerability after a four-week treatment period of once daily six days per week (every day except Sunday) applications compared to the matching vehicle and positive references Daivonex® cream (Leo Pharma), Daivobet® ointment (Leo Pharma) and calcipotriol ointment (Sandoz)) ;Primary end point(s): Change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) at end of treatment(Day 29) compared to baseline;Timepoint(s) of evaluation of this end point: 4 weeks (Baseline to Day 29) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical criteria: - Change in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits (Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, Day 25) compared to baseline - Change in Total Clinical Score (TCS) at individual visits (Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, Day 25) compared to Baseline. Ultrasonography: Change in lesion thickness (total and echo-poor band) measured by ultrasound at Day 15 and end of treatment compared to baseline;Timepoint(s) of evaluation of this end point: see E.5.2 | — |
Countries
France
Contacts
Public ContactProject Director
Drug Delivery Solutions Aps (DDS) c/o MC2 Biotek Group
Outcome results
None listed