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

May 25, 2018 updated by: University Hospital, Rouen

Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rouen, France, 76031
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protopic Arm
Protopic® 0.1% ointment - 2 applications per week for 6 months
Protopic® 0.1% ointment - 2 applications per week for 6 months
Other Names:
  • Tacrolimus
Active Comparator: Mycoster Arm
2 applications per week for 6 months
Mycoster 1% - 2 applications per week for 6 months
Other Names:
  • Ciclopirox olamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of the maintenance of complete or almost complete clinical remission
Time Frame: 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.
18 months after inclusion (Visit (V) 4 last visit)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Pascal JOLY, Professor, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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