Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be important to have a maintenance treatment for severe forms of seborrheic dermatitis witch is both effective and relatively well tolerated to reduce the frequency of relapses, prolong remissions obtained after attack treatment and reduce the use of topical steroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Protopic® 0.1% ointment - 2 applications per week for 6 months
Mycoster 1% - 2 applications per week for 6 months
Rouen University Hospital
Rouen, France
duration of the maintenance of complete or almost complete clinical remission
The primary endpoint will be the duration of the maintenance of complete or almost complete clinical remission obtained after the initial treatment. This period is defined as the time from randomization to the first occurrence of relapse noted by the dermatologist.
Time frame: 18 months after inclusion (Visit (V) 4 last visit)
Tolerance of 2 treatments
Tolerance of 2 treatments Mycoster (R) and Protocopic (R)
Time frame: between 10 days and 18 months after inclusion (V3 (Day (D)10 to D180)), 30 days after inclusion (Visit D30), after 90 days after inclusion (D90) and after 120 days after inclusion (D120) and 180 days after inclusion (Visit V4)
Number of Relapses
Number of Relapses requiring the resumption of topical corticosteroid treatment,
Time frame: 180 days after inclusion (Visit V4)
Cumulative amount of corticosteroids applied
Cumulative amount of corticosteroids applied by the patients during the study period to control their outbreaks
Time frame: between 10 days and 18 months after inclusion (V3 (D10 to D180)), 30 days after inclusion (Visit D30), after 90 days after inclusion (D90) and after 120 days after inclusion (D120) and 180 days after inclusion (Visit V4)
quality of life of patients
quality of life of patients
Time frame: Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180)
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