- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02004860
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
Conditions
Intervention / Treatment
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
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-
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Rouen, France, 76031
- Rouen University Hospital
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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)
- 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,
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
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Protopic® 0.1% ointment - 2 applications per week for 6 months
Other Names:
|
Active Comparator: Mycoster Arm
2 applications per week for 6 months
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Mycoster 1% - 2 applications per week for 6 months
Other Names:
|
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.
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18 months after inclusion (Visit (V) 4 last visit)
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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)
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Tolerance of 2 treatments Mycoster (R) and Protocopic (R)
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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)
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Number of Relapses
Time Frame: 180 days after inclusion (Visit V4)
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Number of Relapses requiring the resumption of topical corticosteroid treatment,
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180 days after inclusion (Visit V4)
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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
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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)
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quality of life of patients
Time Frame: Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180)
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quality of life of patients
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Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Skin Diseases, Eczematous
- Sebaceous Gland Diseases
- Dermatitis
- Dermatitis, Seborrheic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Antifungal Agents
- Calcineurin Inhibitors
- Tacrolimus
- Ciclopirox
Other Study ID Numbers
- 2011/104/HP
- 2011-004186-32 (EudraCT Number)
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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