Rouen University Hospital
Rouen, 76031, France
NCT Number: NCT02004860
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Rouen, 76031, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Protopic® 0.1% ointment - 2 applications per week for 6 months
Other names: Tacrolimus
Mycoster 1% - 2 applications per week for 6 months
Other names: Ciclopirox olamine
Time frame: 18 months after inclusion (Visit (V) 4 last visit)
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: 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)
Tolerance of 2 treatments Mycoster (R) and Protocopic (R)
Time frame: 180 days after inclusion (Visit V4)
Number of Relapses requiring the resumption of topical corticosteroid treatment,
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)
Cumulative amount of corticosteroids applied by the patients during the study period to control their outbreaks
Time frame: Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180)
quality of life of patients
University Hospital, Rouen
Other
Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face
Acronym: Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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