Tacrolimus Ointment Interest (PROTOPIC �) in the Maintenance Treatment of Severe Seborrheic Dermatitis
Information source: University Hospital, Rouen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Seborrheic Dermatitis
Intervention: Protopic (R) (Drug); Mycoster (R) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Hospital, Rouen Official(s) and/or principal investigator(s): Pascal JOLY, Professor, Study Director, Affiliation: University Hospital, Rouen
Overall contact: Pascal JOLY, Professor, Phone: 2 32 88 68 41, Ext: +33, Email: pascal.joly@chu-rouen.fr
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.
Clinical Details
Official title: Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: duration of the maintenance of complete or almost complete clinical remission
Secondary outcome: Tolerance of 2 treatmentsNumber of Relapses Cumulative amount of corticosteroids applied quality of life of patients
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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,
Locations and Contacts
Pascal JOLY, Professor, Phone: 2 32 88 68 41, Ext: +33, Email: pascal.joly@chu-rouen.fr
Rouen University Hospital, Rouen 76031, France; Recruiting Pascal Joly, Professor, Phone: 2 32 88 68 41, Ext: +33, Email: pascal.joly@chu-rouen.fr philippe Musette, professor, Phone: 2 32 88 68 41, Ext: +33, Email: philippe.musette@chu-rouen.fr Pascal JOLY, Pr, Principal Investigator
Additional Information
Starting date: January 2014
Last updated: March 23, 2015
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