EUCTR2007-000418-35-DE进行中（未招募）不适用
A double-blind, randomised, parallel group, placebo-controlled dose finding Phase II study to compare the efficacy and safety of topically applied Avugane™ of different concentrations in subjects with mild to moderate acne vulgaris
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •1. Clinically confirmed diagnosis of facial acne papulopustulosa or acne
- •papulopustulosa et comedonica with a mild to moderate intensity (grade 2 to 8
- •according to the revised Leeds Scale of Acne Grading13) and with at least 12
- •inflammatory lesions
- •2. Patients aged between 18 and 40
- •3. A general good health condition as confirmed by a physical examination and by
- •medical history
- •4. Female Subjects of childbearing potential with a negative pregnancy test at the
- •screening visit and must practice a highly effective method of contraception (implant,
- •injectable, combined oral contraceptive, IUD, strict sexual abstinence or
- •vasectomised partner) during the study (including the 4 weeks after end of
- •treatment) combined with a barrier method (e.g. diaphragm or condom)
- •5. Acceptance of oil-free skin care products
- •6. Acceptance to abstain from any other systemic or topical acne treatment during trial
- •7. Acceptance to abstain from sun bathing and the solarium
- •8. Signed informed consent
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of any acneiform diseases like exogenous acne, drug induced acne,
- •cosmetic induced acne
- •2. Localisation of acne that requires treatment predominantly on the chest and/or the
- •3. Patients with a personal or family history of cutaneous epithelioma
- •4. Nursing women
- •5. History or presence of disorders commonly accepted as contraindications to the
- •treatment with 2-propylpentanoic acid (2-PPA):
- •A.Evidence in the subject's and family medical history of liver diseases or apparent
- •severe functional disorders of liver and pancreas
- •B.Functional disorders of liver with fatal outcome during valproic acid (2-PPA)
- •therapy in siblings.
- •C.Hepatic porphyria
- •D.Present liver disease (bilirubin should be below UNL 22µmol/L, ALT below UNL of
- •60 IU/L, or AST below UNL of 45 U/L)
- •E.Presence of pancreatic dysfunction (p-alpha-amylase below UNL 300 IU/L)
- •F.Decreased renal function (serum creatinine below UNL of 133 µmol/L in men, 115
- •µmol/L in women)
- •G.Haematologic disorder like bleeding disorder or coagulation abnormalities (partial
- •thromboplastin time (PTT) > 1.5 x UNL), bone marrow disorders
- •H.Porphyria, metabolic diseases (especially congenital enzymopathy), systemic
- •lupus erythematosus or hypoproteinaemia
- •I.Hypertension (BP above 140/90)
- •6. Other skin conditions that might interfere with acne diagnosis and/or evaluation
- •(such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and
- •papulo-pustular rosacea)
- •7. History of hypersensitivity to valproic acid (2-PPA) or any other ingredient in the test
- •drug or in the placebo
- •8. Treatment with any systemic acne drug within the last 3 months prior to the day 1
- •assessment and within 6 months for systemic retinoids
- •9. Treatment with any other topical acne drug within the last 14 days prior to the day
- •1 assessment
- •10. Presence of a significant uncontrolled cardiovascular, neurologic, malignant,
- •psychiatric, respiratory or hypertensive disease
- •11. Recent history of alcohol or any other substance abuse
- •12. Treatment with any experimental drug within 30 days prior to the day 1
- •13. Inability to comply with the study protocol
研究者
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