Chronic stable plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Betamethasone dipropionate 0.64 mg/g _Salicylic acid 30 mg/g
Pharmaceutical Form: Ointment
INN or Proposed INN: Betamethasone Dipropionate
CAS Number: 5593-20-4
Current Sponsor code: n.
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women and men = 18 years of age - Written consent to study participation after patient information by the investigator - Clinical diagnosis of chronic stable (at least 6 months) plaque psoriasis amenable to topical treatment and involving arms and/or legs and/or trunk - Psoriasis affecting = 10% of the total body surface area (BSA) - A modified PASI score of = 5 to = 15 at baseline - For women of childbearing potential: Application of an efficient contraceptive method during the whole study - For women of childbearing potential: Pregnancy test with negative result prior to study start 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: • Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis • Systemic therapy of psoriasis within the last 4 weeks before study inclusion and during the study • Use of topical anti-psoriatic therapy (including topical retinoids, topical corticosteroids, vitamin D analogues, salicylic acid, dithranol, coal tar) within two weeks prior study inclusion • Known intolerance or hypersensitivity against salicylic acid, betamethasone dipropionate or other glucocorticoids or any of the other ingredients in the study medication • History of psoriasis unresponsive to topical treatment • Current or past history of renal insufficiency or severe hepatic disorders • Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster, varicella), fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds and vaccination reactions • Other inflammatory skin disease in the treatment area that may confound the evaluation of the stable plaque psoriasis (e.g. atopic dermatitis, contact dermatitis, tinea corporis) • Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment area, which could interfere with the rating of efficacy and safety parameters • Other severe acute or chronic concomitant disease with severe impairment of the general condition • Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible • Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data • Reasonable doubt concerning the co-operation of the patient • Participation in another clinical study within the last 30 days prior to inclusion in this study • Participation in this study at an earlier date • Women with existing or intended pregnancy or during lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy and safety of a new ointment containing 0.64 mg/g Betamethasone dipropionate and 30 mg/g Salicylic acid vs. the originator Diprosalic(R) ointment (Reference) vs. vehicle in patients with chronic stable plaque psoriasis;Secondary Objective: see E5 (endpoints);Primary end point(s): Primary efficacy endpoint to be analyses is the percent change of a modified Psoriasis Area and Severity Index (mPASI) ("excluding the head") between start of treatment (Visit 1) and end of treatment (EoT, Visit 4);Timepoint(s) of evaluation of this end point: Start of therapy (Visit 1) and end of therapy (Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percent change of the total body surface area (BSA) affected by psoriasis between visits. - Course of the individual Psoriasis activity parameters erythema, desquamation and induration at Visit 0, Visit 1, Visit 2, Visit 3 and Visit 4, respectively. - Course of the individual Psoriasis area scores separately for each body part at Visit 0, Visit 1, Visit 2, Visit 3 and Visit 4 respectively. - Percent change of the modified Psoriasis Area and Severity Index (mPASI) between visits. - Reduction in modified PASI score of >75% between Visit 1 (Day 0) and Visit 4 (EoT). - Reduction in modified PASI score of >50% between Visit 1 (Day 0) and Visit 4 (EoT). - Change of the Investigator`s Global Assessment (IGA) between each visit. - Change of the Patient`s Psoriasis Global Assessment (PPGA) between each visit. - Controlled disease (defines as "clear" or "almost clear") according to the IGA at Visit 4. - Controlled disease (defined as "clear" or "almost clear") according to the PPGA at Visit 4. - Number and classification of advere events - Evaluation of tolerability by the investigator and by the patient at Visit 2 - Visit 4 - Hemic and clinical chemistry parameters (haemoglobin, haematocrit, erythrocytes, leukocytes, thrombocytes, sodium, potassium, creatinine, bilirubin, glucose, sGOT, SGPT, gamma-GT and cortisol) at screening visit (Visit 0) and EoT (Visit 4) - Change in the serum cortisol level from screening visit (Visit 0) to end of week 3 (EoT; Visit 4) ;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E5.2 above | — |
Countries
Germany
Contacts
Public ContactClinical Research Department
Dermapharm AG
Outcome results
None listed