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

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ClinicalTrials.gov Identifier: NCT02004860
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Severe Seborrheic Dermatitis Drug: Protopic (R) Drug: Mycoster (R) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face
Study Start Date : January 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Protopic Arm
Protopic® 0.1% ointment - 2 applications per week for 6 months
Drug: Protopic (R)
Protopic® 0.1% ointment - 2 applications per week for 6 months
Other Name: Tacrolimus

Active Comparator: Mycoster Arm
2 applications per week for 6 months
Drug: Mycoster (R)
Mycoster 1% - 2 applications per week for 6 months
Other Name: Ciclopirox olamine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Number of Relapses [ Time Frame: 180 days after inclusion (Visit V4) ]
    Number of Relapses requiring the resumption of topical corticosteroid treatment,

  3. 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

  4. quality of life of patients [ Time Frame: Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180) ]
    quality of life of patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004860


Locations
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France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Study Director: Pascal JOLY, Professor University Hospital, Rouen

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02004860     History of Changes
Other Study ID Numbers: 2011/104/HP
2011-004186-32 ( EudraCT Number )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Keywords provided by University Hospital, Rouen:
local immunosuppressive
Maintenance therapy

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Ciclopirox
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents