EUCTR2012-004965-41-SK进行中（未招募）1 期
A Randomised, Double-blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Topically Applied DGLA Cream in Patients with Mild to Moderate Acne Vulgaris - Safety and Efficacy Study of DGLA Cream in Patients with Acne Vulgaris
Dignity Sciences Limited0 个研究点目标入组 150 人开始时间: 2013年4月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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 Grading) and with at least 12 inflammatory lesions excluding the nose
- •2. General good health as confirmed by a physical examination and by medical history
- •3. Acceptance to abstain from any other systemic or topical acne treatment during trial
- •4. Acceptance to abstain from prolonged UV exposure via intensive sunbathing, the use of tanning equipment or outdoor pursuits such as mountain sports activities
- •5. Male or female patients aged 16 to 40 years on the day of signing the informed consent form (ICF).
- •6. Patients who are able and willing to give signed informed consent (ICF).
- •7. Body mass index (BMI) of between 18 and 30 kg/m2 inclusive.
- •8. Patients taking oral contraceptives containing compounds with known effects on acne are allowed providing that the subject has been on stable dose for 6 months prior to enrollment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 126
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Females with a positive pregnancy test at baseline
- •2. Females of childbearing potential and female partners of male patients who have not used for 6 months prior to the trial and are not willing to use for the duration of the trial; a safe contraceptive measure (e.g. IUD or oral contraceptives, diaphragm or condom if used in combination with a spermicide)
- •3. Diagnosis of any acneiform diseases like exogenous acne, drug induced acne, cosmetic induced acne
- •4. Presence of more than 2 nodules on the face. Up to two nodules are allowed.
- •5. Localisation of acne that requires treatment predominantly on the chest and/or the back
- •6. Patients with any clinically significant abnormal laboratory results at screening (biochemistry, haematology, urinalysis).
- •7. Other skin conditions that might interfere with acne diagnosis and/or evaluation (such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and papulo-pustular rosacea)
- •8. Treatment with any of the following medications within a timeframe prior to screening assessment of:
- •-Corticosteroids, antibiotics (except plain penicillins) 4 weeks
- •-Other systemic acne treatments (including isotretinoin) 6 months
- •-Spironolactone 3 months.
- •9. Patients taking oral contraceptives containing compounds with known effects on acne; these include norethisterone/norethindrone, drospirenone, ciproterone acetate and norgestimate and other oral contraceptives who are not on stable dose for 6 months prior to enrollment.
- •10. Patients taking hormonal contraception solely for the control of acne
- •11. Treatment with any other topical acne drug within the last 14 days prior to the screening assessment
- •12. Presence of a significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease
- •13. Recent history of alcohol or any other substance abuse
- •14. Treatment with any experimental drug within 30 days prior to the screening assessment
- •15. Inability to comply with the study protocol
- •16. Patients who have received phototherapy (UVA, UVB) within 4 weeks of screening (Visit 1).
- •17. Patients with clinically significant impairment of renal or hepatic function.
- •18. Patients with a history of hypersensitivity to any substance in the IMP.
- •19. Patients with severe acne vulgaris or nodulocystic acne
- •20. Patients with a history of clinically relevant ECG abnormalities.
- •21. Patients with a known medical history of chronic infectious disease (HCV, HBV, HIV).
- •22. Patients who are investigational site staff members or relatives of those site staff members or patients who are relatives of Dignity Sciences employees directly involved in the conduct of the trial.
研究者
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