EUCTR2017-002612-14-DE进行中（未招募）1 期
Preliminary efficacy and safety of Apremilast in the treatment of acne conglobata: A phase II, single centre, open label, proof of concept study for the treatment of acne conglobata with the PDE-4 inhibitor Apremilast (APACCO-Study)
Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME)0 个研究点目标入组 16 人开始时间: 2019年2月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Main inclusion criteria
- •Diagnosis of acne conglobata for a minimum of 6 months
- •Active condition of acne conglobata
- •No clinical significant or severe abnormality of skin (e.g. scars, other severe skin disease) based on medical/medication history or physical examination as determined by the treating physician
- •Number of abscesses = 2
- •Minimum IGA of 2 (5-point scale) of severity of acne conglobata
- •Written informed consent obtained from the patients prior to the initiation of any protocol-required procedures
- •Compliance to study procedures and study protocol
- •Age 18 – 65 years
- •Main inclusion criteria related to prior treatments:
- •patients who do not tolerate or no longer tolerate therapies or for whom the following treatment options are contraindicated:
- •oTopical retinoid therapy
- •oIsotretionin and/or acitretin as standard therapy
- •oTopical treatment with antibiotics, glucocorticoids, retinoids, Vit-D-analogue, calcineurin inhibitors
- •osystemic antibiotics, systemic glucocorticoids
- •osystemic retinoids
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main exclusion criteria
- •Previous use of Apremilast, or any other PDE-4 inhibitor.
- •Exclusion criteria related to IMP
- •According to SmPC
- •Known hypersensitivity to any component of the IMP
- •Current use of strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, and St. John’s Wort)
- •Exclusion criteria related to general health
- •Active dermatologic conditions which may confound the diagnosis of acne conglobata or would interfere with the assessment of treatment (e.g., acne inversa, atopic dermatitis, seborrheic dermatitis, ichtyosis, and psoriasis)
- •History of clinically significant infection within the last 4 weeks before screening, which, in the opinion of the treating physician, may compromise the safety of the patient
- •Presentation of special type of acne, including but not limited to:
- •oMedication related acne (e.g., steroid abuse)
- •oAcne with facial edema
- •oRecalcitrant acne
- •oAcne cosmetic, pomade acne
- •oAcne mechanica
- •History of any kind of cancer or carcinoma in situ within the last 5 years before screening
- •History of chronic alcohol/drug abuse within the last 12 months before screening
- •Pregnant or breastfeeding women
- •Females of childbearing potential not willing to use effective contraception (defined as PEARL index <1 - e.g. hormonal contraceptive containing estrogen and progesterone, or progesterone only, applied orally, intravaginal, transdermal or to be injected, IUD) for the duration of the study, strict abstinence, or partner had a vasectomy
- •Severe kidney insufficiency (GFR < 30 ml/min)
- •Any severe disease, which, in the opinion of the treating physician, may interfere or worsen the acne conglobata or could become a safety problem for patients
- •History of or current Hepatitis-B, Hepatitis-C or HIV infection
- •Any active medication which suppresses the immune system, including disease modifying anti-rheumatic drugs (DMARDs)
- •Current participation in another investigational clinical trial or participation in another investigational clinical trial within 30 days prior to screening
- •Major surgery within the last 4 weeks before screening
- •Subject susceptible to take a local corticosteroid treatment (class I – III) during the study except inhaled or topic when needed to treat a condition outside the treatment area (head, neck, upper trunk)
- •Exclusion criteria related to prior treatments:
- •Washout times for previous therapy for acne conglobata before screening:
- •o1 week for any topical treatment (e.g., antibiotics, glucocorticoids, retinoids, Vit-D-analogue, calcineurin inhibitors)
- •o4 weeks for any systemic antibiotics, systemic glucocorticoids or UV-therapy
- •o12 weeks for any systemic retinoids or any investigational drug
- •oPatients who take any kind of contraceptive therapy (eg. estrogene, gestagene) with known positive effect on acne must be on stable dosage for a minimum of 6 month
- •Exclusion criteria related to formal aspects:
- •Underage or incapable patients
- •Patients who are legally institutionalized
研究者
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