Psoriasis Vulgaris
Conditions
Interventions
Product Name: CT327
Product Code: CT327
Pharmaceutical Form: Cream
INN or Proposed INN: CT 327
Current Sponsor code: CT 327
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Sponsors
Creabilis Sàrl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Subject or partner of subject not using an adequate and appropriate form of contraception such as condom (male) or oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch (female) •Subject or partner of subject are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter •Allergy to test drug or any other ingredient •Usage of topical corticosteroids or other topical treatments for PV within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, nonsteroidals, immune-suppressants, or immune-modulating drugs, or treatment with light). •Received treatment with systemic or locally acting medications which might counter or influence the study aim •Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses •Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the patient's response to the study drug •Have immune-compromised status (such as known human immunodeficiency virus infection) •Have a history of malignancy, excluding basal cell carcinoma of the skin •Have an active intercurrent infection •Suffer from erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of CT 327, when administered twice daily as a topical cream to lesions of Psoriasis Vulgaris (PV) in comparison to placebo in terms of improvements from baseline in study group (within patient comparison by McNemar test) on: Proportion of lesions with a reduction in m-PASI-score of > 50% for CT 327 vs placebo treated lesions at Week 8 ;Secondary Objective: To investigate the efficacy and safety of CT 327, when administered twice daily as a topical cream to lesions of Psoriasis Vulgaris (PV) in comparison to placebo in terms of: EFFICACY: 1) Proportion of lesions with a reduction in mPASI-score of > 75% at week 8 compared to baseline values. 2) Time to onset of effect: At each visit and for each patient, reduction in m-PASI-score compared to baseline values will be determined. 3)IGA (Investigator Global Assessment) will be assessed at week 8 SAFETY: 1) local tolerability 2) systemic safety and tolerability 3) absorption of CT 327 to the systemic circulation (Blood levels of CT 327 and K252a);Primary end point(s): To assess the efficacy of an 8-week treatment of CT 327 vs Placebo in terms of improvements from baseline in study group (within patient comparison by McNemar test) on: Proportion of lesions with a reduction in m-PASI-score of > 50% for CT 327 vs placebo treated lesions at Week 8 | — |
Countries
United Kingdom
Outcome results
None listed