EUCTR2018-003307-19-PL进行中（未招募）1 期
A double-blind, randomized, vehicle-controlled clinical multi-center study to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel, 2 and 5%, applied once daily for 12 weeks in patients with facial acne vulgaris - GEDACNE
PPM SERVICES S.A.0 个研究点目标入组 450 人开始时间: 2019年5月6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
- 450
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.Informed consent obtained
- •2.Male and female patients aged = 12 to = 30 years old inclusive;
- •3.Diagnosis: Patients with facial acne vulgaris with an investigator’s global assessment (IGA) score of 3–4 at screening and baseline visits;
- •4.Inflammatory lesions: Patients with = 20 and = 100 inflammatory lesions (papules and pustules) on the face (excluding the nose) and = 1 nodules;
- •5.Non-inflammatory lesions: Patients with = 20 and = 100 non-inflammatory lesions (open and closed comedones) on the face (excluding the nose);
- •6.Full comprehension: Patient and parent(s)/guardian for <18 years old patient’s ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study;
- •7.Contraception and fertility: Women of childbearing potential must be using an effective contraception method during the entire duration of the study. Stable treatment period is required for the following reliable methods of contraception: • Hormonal oral, implantable, transdermal, or injectable contraceptives must be stable for at least 6 months before the screening visit • A non-hormonal intrauterine device (IUD) must be started at least 2 months before the screening visit
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 225
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 225
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with spontaneously improving or rapidly deteriorating acne within at least 3 months before study baseline. Patients who have a known history of acne unresponsive to topical and/or oral treatments. In particular subjects with history of persistent acne (a continuation of the disease from adolescence into adulthood) and subjects with history of relapsing acne. Patients with generalized or localized acne forms other than acne vulgaris, e.g., acne conglobata, acne fulminans, acne rosacea, secondary acne (chloracne, drug-induced acne, etc), nodule-cystic acne, acne tarda or acne requiring systemic treatment. 2.Patients who have a beard or who intend to grow a beard and/or to perform a facial tattoo during the study. Patient has facial hair or facial tattoos that could interfere with the study assessments in the opinion of the investigator.
- •3.Patients with other active skin diseases (e.g., urticaria, atopic dermatitis, sunburn, seborrheic dermatitis, perioral dermatitis, rosacea, skin malignancies) or active skin infections in the facial region (bacterial, fungal, or viral) or any other facial disease or condition that might interfere with the evaluation of acne or place the patient at unacceptable risk.
- •4.Known or suspected hypersensitivity to any active or inactive ingredient in the study products. Patients with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients
- •5. Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the-counter topical therapies for the treatment of acne including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide salicylates, a-hydroxy/glycolic acid, any other topical cosmetic therapy for acne and retinoids on the face.
- •6.Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, facial application of products containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non-mild cleansers or moisturizers containing retinol, salicylic or alpha- or beta-hydroxy acids, facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping).
- •7.Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, phototherapy for the treatment of acne including but not limited to: UV-A, UV-B, heliotherapy. Patients who have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the study. 8.Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, systemic therapies for the treatment of acne including but not limited to: antibiotics, isotretinoin. Other systemic therapy which, in the opinion of the investigator, could affect the patient’s acne (i.e., anabolics, lithium, EGFR inhibitors, iodides, systemic corticosteroids or other immunosuppressants).
- •9.Known systemic diseases that can lead to acneiform eruptions: a. Increased androgen production. 1) Adrenal origin: e.g., Cushing’s disease, 21-hydroxylase deficiency; 2) Ovarian origin: e.g., polycystic ovarian syndrome, ovarian hyperthecosis b. Cryptococcosis disseminated c. Dimorphic fungal infections
- •10.Participation in the evaluation of any investigational product or device within 30
研究者
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