NCT02004860已完成3 期
Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- duration of the maintenance of complete or almost complete clinical remission
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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,
研究组 & 干预措施
Protopic Arm
Experimental
Protopic® 0.1% ointment - 2 applications per week for 6 months
干预措施: Protopic (R) (Drug)
Mycoster Arm
Active Comparator
2 applications per week for 6 months
干预措施: Mycoster (R) (Drug)
结局指标
主要结局
duration of the maintenance of complete or almost complete clinical remission
时间窗: 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.
次要结局
- 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))
研究者
研究点 (1)
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