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

Last updated: May 25, 2018
Sponsor: University Hospital, Rouen
Overall Status: Completed

Phase

3

Condition

Allergy

Rash

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT02004860
2011/104/HP
2011-004186-32
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thestudy or postmenopausal women.

  • in Phase 2: Phase 2: "Randomization" (blind)
  1. Patient achieved a complete or almost complete clinical remission after theinitial treatment,

  2. known immunodeficiency (HIV patient receiving chemotherapy) or immunosuppressivetherapy 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 scalppsoriasis (elbows, knees ...), by referring to the possibility that the faciallesions correspond to lesions sebopsoriasis,

  5. woman pregnant, nursing or in childbearing potential without effectivecontraception,

  6. man wishing to have a child during the study period,

  7. Ultra Violet (UV) phototherapy or usual realization of UV sessions aestheticpurposes,

  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 todeficiency dermatitis,

  14. participation in a clinical trial on the Seborrheic dermatitis in the previous 90days,

  15. patient with lesions considered potentially malignant or pre-cancerous,

  16. patient with abnormal skin barrier.

Exclusion

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 completeclinical remission after the initial treatment,

Study Design

Total Participants: 120
Study Start date:
January 01, 2014
Estimated Completion Date:
October 31, 2017

Connect with a study center

  • Rouen University Hospital

    Rouen, 76031
    France

    Site Not Available

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