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

Phase 3

Completed

• Conditions: Severe Seborrheic Dermatitis
• Interventions: Drug: Mycoster (R); Drug: Protopic (R)

• Registration Number: NCT02004860
• Lead Sponsor: University Hospital, Rouen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Study Start: 2014-01
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycoster Arm	Mycoster (R)	2 applications per week for 6 months
Protopic Arm	Protopic (R)	Protopic® 0.1% ointment - 2 applications per week for 6 months

Primary Outcome Measures

Name	Time	Method
duration of the maintenance of complete or almost complete clinical remission	18 months after inclusion (Visit (V) 4 last visit)	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.

Secondary Outcome Measures

Name	Time	Method
Tolerance of 2 treatments	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)	Tolerance of 2 treatments Mycoster (R) and Protocopic (R)
quality of life of patients	Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180)	quality of life of patients
Number of Relapses	180 days after inclusion (Visit V4)	Number of Relapses requiring the resumption of topical corticosteroid treatment,
Cumulative amount of corticosteroids applied	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)	Cumulative amount of corticosteroids applied by the patients during the study period to control their outbreaks

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France