Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004186-32 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protopic Arm | Experimental | Protopic® 0.1% ointment - 2 applications per week for 6 months |
|
| Mycoster Arm | Active Comparator | 2 applications per week for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protopic (R) | Drug | Protopic® 0.1% ointment - 2 applications per week for 6 months |
|
| 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) |
| 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) |
Not provided
Inclusion Criteria:
in Phase 1: Attack Treatment (open)
in Phase 2: Phase 2: "Randomization" (blind)
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,
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pascal JOLY, Professor | University Hospital, Rouen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rouen University Hospital | Rouen | 76031 | France |
Not provided
| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D000077768 | Ciclopirox |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003510 | Cyclohexanes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mycoster (R) | Drug | Mycoster 1% - 2 applications per week for 6 months |
|
|
| 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) |
| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011728 | Pyridones |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |