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

University Hospital, Rouen

Status and phase: Completed; Phase 3

Conditions: Severe Seborrheic Dermatitis

Treatments: Drug: Mycoster (R); Drug: Protopic (R)

Study type: Interventional

Funder types: Other

Identifiers

NCT02004860

2011/104/HP

2011-004186-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• in Phase 1: Attack Treatment (open)

  1. over the age of eighteen patient,
  2. Seborrheic dermatitis Severe,
  3. participation with an informed consent,
  4. Women of childbearing age in effective contraception for the duration of the study or postmenopausal women.

• in Phase 2: Phase 2: "Randomization" (blind)

  1. Patient achieved a complete or almost complete clinical remission after the initial treatment,
  2. known immunodeficiency (HIV patient receiving chemotherapy) or immunosuppressive therapy or biotherapy,
  3. patient taking regular systemic corticosteroids at a dose> 20 mg / day
  4. 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,
  5. woman pregnant, nursing or in childbearing potential without effective contraception,
  6. man wishing to have a child during the study period,
  7. Ultra Violet (UV) phototherapy or usual realization of UV sessions aesthetic purposes,
  8. Seborrheic dermatitis symptomatic of an underlying disease known or revealing
  9. history of cancer or lymphoma,
  10. progressive cancer or lymphoma,
  11. Seborrheic dermatitis exclusively affecting the scalp,
  12. known allergy to one-component products study ,
  13. malnourished patient or sick history of chronic pancreatitis by a suspect to deficiency dermatitis,
  14. participation in a clinical trial on the Seborrheic dermatitis in the previous 90 days,
  15. patient with lesions considered potentially malignant or pre-cancerous,
  16. 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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Protopic Arm

Experimental group

Description:

Protopic® 0.1% ointment - 2 applications per week for 6 months

Treatment:

Drug: Protopic (R)

Mycoster Arm

Active Comparator group

Description:

2 applications per week for 6 months

Treatment:

Drug: Mycoster (R)