Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face

Conditions
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Severe Seborrheic Dermatitis

Intervention / Treatment
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* Drug: Protopic (R)
* Drug: Mycoster (R)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: in Phase 1: Attack Treatment (open) over the age of eighteen patient, Seborrheic dermatitis Severe, participation with an informed consent, Women of childbearing age in effective contraception for the duration of the study or postmenopausal women. in Phase 2: Phase 2: Randomization (blind) Patient achieved a complete or almost complete clinical remission after the initial treatment, known immunodeficiency (HIV patient receiving chemotherapy) or immunosuppressive therapy or biotherapy, patient taking regular systemic corticosteroids at a dose> 20 mg / day erythematous lesions with topography other than the face and evocative scalp psoriasis (elbows, knees ...), by referring to the possibility that the facial lesions correspond to lesions sebopsoriasis, woman pregnant, nursing or in childbearing potential without effective contraception, man wishing to have a child during the study period, Ultra Violet (UV) phototherapy or usual realization of UV sessions aesthetic purposes, Seborrheic dermatitis symptomatic of an underlying disease known or revealing history of cancer or lymphoma, progressive cancer or lymphoma, Seborrheic dermatitis exclusively affecting the scalp, known allergy to one-component products study , malnourished patient or sick history of chronic pancreatitis by a suspect to deficiency dermatitis, participation in a clinical trial on the Seborrheic dermatitis in the previous 90 days, patient with lesions considered potentially malignant or pre-cancerous, patient with abnormal skin barrier. Exclusion Criteria: in Phase 1: Attack Treatment (open) 1) Patient had already been treated with Protopic ® for Seborrheic Dermatitis, Phase 2: Randomization (blind) 1) Patient with no complete or almost complete clinical remission after the initial treatment,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protopic Arm<br>Protopic® 0.1% ointment - 2 applications per week for 6 months | Drug: Protopic (R)<br>* Protopic® 0.1% ointment - 2 applications per week for 6 months<br>* Other names: Tacrolimus;|
| Active Comparator: Mycoster Arm<br>2 applications per week for 6 months | Drug: Mycoster (R)<br>* Mycoster 1% - 2 applications per week for 6 months<br>* Other names: Ciclopirox olamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months after inclusion (Visit (V) 4 last visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of 2 treatments | Tolerance of 2 treatments Mycoster (R) and Protocopic (R) | 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, | 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 | 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 | Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local immunosuppressive, Maintenance therapy