Vergleich eines bekannten Arzneimittels zur Behandlung der Schuppenflechte des Kopfes (Kombination aus 2 Wirkstoffen) mit einem neuen Arzneimittel (gleiche Wirkstoffe) und der Grundlage ohne Wirkstoff.

Conditions: Psoriasis capitis
MedDRA version: 14.1Level: LLTClassification code 10037157Term: Psoriasis of scalpSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2010-024033-24-DE

Lead Sponsor: Dermapharm AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) Men or women, 18 years or older.
2) Written consent form.
3) Diagnosis: Psoriasis of the scalp.
4) At least 20% of the scalp affected.
5) Less than 50% of the body surface affected.
6) Less then 30 % of the body surface affected if the dermatosis was progressive within the last 4 weeks.
7) Activity parameter erythema, desquamation, thickening and pruritus (Score 0 to 3): Sum score equal to or more than 6 AND desquamation and erythema equal to or more than 4 AND desquamation equal to or more than 2.
8) Women of child bearing potential: Use of a highly effective method of contraception during the whole course of the study.
9) Negative pregnancy test prior to study start.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

1) Systemtic psoriasis therapy within 4 weeks prior to screening.
2) Topical treatment or other therapies (e. g. UV exposure) of the psoriasis capitis within 2 weeks prior to screening.
3) Known intolerance or hypersensitivity against betamethasone, salicylic acid or other components of the vehicle.
4) Severe heart failure, severe insufficiency of the circulatory system, severe hepatic or renal insufficiency, severe respiratory insufficiency, neoplasm.
5) Severe acute or chronic concomitant disease seriously affecting the general condition.
6) 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.
7) Concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data.
8) Well-founded doubt on the co-operation of the patient.
9) Dementia or other severe intellectual problems, that make evaluation of patient history or self-assessment of the patient impossible.
10) Excessive use of alcohol, drugs, medication or nicotine.
11) Participation of the patient in another clinical trial within the last 30 days prior to inclusion or during this study.
12) Former participation of the patient in this clinical trial.
13) Pregnant women or planned pregnancy or lactating women.