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

Primary Purpose

Severe Seborrheic Dermatitis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Protopic (R)
Mycoster (R)
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Seborrheic Dermatitis focused on measuring local immunosuppressive, Maintenance therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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,

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Protopic Arm

Mycoster Arm

Arm Description

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

2 applications per week for 6 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tolerance of 2 treatments
Tolerance of 2 treatments Mycoster (R) and Protocopic (R)
Number of Relapses
Number of Relapses requiring the resumption of topical corticosteroid treatment,
Cumulative amount of corticosteroids applied
Cumulative amount of corticosteroids applied by the patients during the study period to control their outbreaks
quality of life of patients
quality of life of patients

Full Information

First Posted
August 26, 2013
Last Updated
May 25, 2018
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02004860
Brief Title
Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis
Acronym
Disease
Official Title
Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Seborrheic Dermatitis
Keywords
local immunosuppressive, Maintenance therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protopic Arm
Arm Type
Experimental
Arm Description
Protopic® 0.1% ointment - 2 applications per week for 6 months
Arm Title
Mycoster Arm
Arm Type
Active Comparator
Arm Description
2 applications per week for 6 months
Intervention Type
Drug
Intervention Name(s)
Protopic (R)
Other Intervention Name(s)
Tacrolimus
Intervention Description
Protopic® 0.1% ointment - 2 applications per week for 6 months
Intervention Type
Drug
Intervention Name(s)
Mycoster (R)
Other Intervention Name(s)
Ciclopirox olamine
Intervention Description
Mycoster 1% - 2 applications per week for 6 months
Primary Outcome Measure Information:
Title
duration of the maintenance of complete or almost complete clinical remission
Description
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.
Time Frame
18 months after inclusion (Visit (V) 4 last visit)
Secondary Outcome Measure Information:
Title
Tolerance of 2 treatments
Description
Tolerance of 2 treatments Mycoster (R) and Protocopic (R)
Time Frame
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)
Title
Number of Relapses
Description
Number of Relapses requiring the resumption of topical corticosteroid treatment,
Time Frame
180 days after inclusion (Visit V4)
Title
Cumulative amount of corticosteroids applied
Description
Cumulative amount of corticosteroids applied by the patients during the study period to control their outbreaks
Time Frame
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)
Title
quality of life of patients
Description
quality of life of patients
Time Frame
Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: in Phase 1: Attack Treatment (open) 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. in Phase 2: Phase 2: "Randomization" (blind) 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, woman pregnant, nursing or in childbearing potential without effective contraception, man wishing to have a child during the study period, Ultra Violet (UV) phototherapy or usual realization of UV sessions aesthetic purposes, Seborrheic dermatitis symptomatic of an underlying disease known or revealing history of cancer or lymphoma, progressive cancer or lymphoma, Seborrheic dermatitis exclusively affecting the scalp, known allergy to one-component products study , malnourished patient or sick history of chronic pancreatitis by a suspect to deficiency dermatitis, participation in a clinical trial on the Seborrheic dermatitis in the previous 90 days, patient with lesions considered potentially malignant or pre-cancerous, 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal JOLY, Professor
Organizational Affiliation
University Hospital, Rouen
Official's Role
Study Director
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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