NCT02004860CompletedPhase 3
Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face
University Hospital, Rouen1 site in 1 country120 target enrollmentStarted: January 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- duration of the maintenance of complete or almost complete clinical remission
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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,
Arms & Interventions
Protopic Arm
Experimental
Protopic® 0.1% ointment - 2 applications per week for 6 months
Intervention: Protopic (R) (Drug)
Mycoster Arm
Active Comparator
2 applications per week for 6 months
Intervention: Mycoster (R) (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Tolerance of 2 treatments(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))
- quality of life of patients(Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180))
- Number of Relapses(180 days after inclusion (Visit V4))
- Cumulative amount of corticosteroids applied(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))
Investigators
Study Sites (1)
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