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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Severe Seborrheic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Protopic Arm

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

Group Type EXPERIMENTAL

Protopic (R)

Intervention Type DRUG

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

Mycoster Arm

2 applications per week for 6 months

Group Type ACTIVE_COMPARATOR

Mycoster (R)

Intervention Type DRUG

Mycoster 1% - 2 applications per week for 6 months

Interventions

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Protopic (R)

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

Intervention Type DRUG

Mycoster (R)

Mycoster 1% - 2 applications per week for 6 months

Intervention Type DRUG

Other Intervention Names

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Tacrolimus Ciclopirox olamine

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No