CompletedPhase 3

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

France120 participantsStarted 2014-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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,

What they're measuring

duration of the maintenance of complete or almost complete clinical remission

Timeframe: 18 months after inclusion (Visit (V) 4 last visit)

Trial details

NCT IDNCT02004860

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

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