Psoriasis capitis MedDRA version: 20.0 Level: LLT Classification code 10037157 Term: Psoriasis of scalp System Organ Class: 100000018190
Conditions
Interventions
Product Name: Calcipotriol 50 µg/g_Betamethasone 0.5 mg/g Gel
Pharmaceutical Form: Gel
INN or Proposed INN: BETAMETHASONE DIPROPIONATE
CAS Number: 5593-20-4
Current Sponsor code: n.a.
Other descripti
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 • Diagnosis of “scalp psoriasis vulgaris” according to generally accepted criteria • Extent of scalp psoriasis involving at least 20% of the total scalp area • For the score values of the activity parameters erythema, desquamation, induration and pruritus (each assessed on a scale from 0 to 3) the following applies: o Sum score of all four parameters = 6 and o Desquamation and erythema = 4 and o Desquamation = 2. • 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 225 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 • Any topical treatment or physical therapy (e.g. UV radiation, retinoids, corticosteroids) of scalp psoriasis within the last 2 weeks before study inclusion • Known intolerance or hypersensitivity against calcipotriol, betamethasone 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 hypercalcemia, vitamin D toxicity, severe 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 manifestions in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds • Other inflammatory skin disease in the treatment area that may confound the evaluation of the scalp psoriasis (e.g. atopic dermatitis, contact dermatitis, tinea capitis) • 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 gel containing 50 µg/g calcipotriol and 0.5 mg/g betamethasone vs. the originator Daivobet (R) Gel vs. vehicle in patients with psoriasis of the scalp. see also E5 (endpoints);Secondary Objective: see E5 (endpoints);Primary end point(s): The primary efficacy endpoint to be analysed is the change of the modified Total Severity Sign Score (mTSS) between start of treatment (Visit 1) and the end of treatment (Visit 5). The mTSS consists of the activity parameters erythema, desquamation, induration and pruritus.;Timepoint(s) of evaluation of this end point: Start of therapy (Visit 1) and end of therapy (Visit 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change of the extent of the scalp psoriasis at each visit • Course of the individual activity parameters erythema, desquamation, induration and pruritus at Visit 1, Visit 2, Visit 3, Visit 4 and Visit 5, respectively • Change of the modified Total Severity Sign Score (mTSS) between start of treatment (Visit 1) and Visit 2, Visit 3, Visit 4 and Visit 5, respectively • Change of the Psoriasis Scalp Severity Index calculated by multiplying each mTSS with the area of the scalp covered by psoriasis between visits • Change of the Investigator`s Global Assessment (IGA) between visits • Proportion of patient with “absence of disease” or “very mild disease” according to the IGA at Visit 5 • Evaluation of Overall Therapeutic Success by the investigator and patient at the final examination • Number and classification of adverse events • Evaluation of tolerability by the investigator and by the patient at all visits under treatment ;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2 above | — |
Countries
Germany
Contacts
Public ContactClinical Department
Dermapharm AG
Outcome results
None listed