EUCTR2017-003796-58-IT进行中（未招募）1 期
AN OPEN LABEL CLINICAL STUDY TO EVALUATE THE LONG-TERM DERMAL SAFETY PROFILE OF 12-WEEKS TOPICAL ADMINISTRATION OF N-ACETYL-GED-0507-34-LEVO GEL 5% IN PATIENTS WITH FACIAL ACNE - NAC-GED-0507 GEL 5% IN ACNE
PPM SERVICES S.A.0 个研究点目标入组 25 人开始时间: 2020年11月4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
- 25
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 and assent: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is = 18 years old, or signed and dated by the parent(s) or the legal guardian if the patient is 12 - <18 years old. An additional informed assent form must be signed by the subject if 12 - <18 years old to confirm his willingness to participate in the study. If the subject becomes 18 years of age during the study, the subject must provide written informed consent at that time to continue study participation
- •2. Sex and Age: Male and female patients aged 18-30 years old inclusive; male patients aged 12 - <18 years old [12-20 years old (Juvenile Acne) and 21-30 (Acne Tarda)]
- •3. Race: White patients (i.e. people with European, Middle Eastern or North African ancestral origin)
- •4. Diagnosis: Patients with facial acne vulgaris with an investigator’s global assessment score of 2-3-4 at screening and baseline visits
- •5. Inflammatory lesions: Patients with =20 and = 100 inflammatory lesions (papules and pustules) on the face (including the nose) and = 1 nodule
- •6. Non-inflammatory lesions: Patients with =20 and = 100 non-inflammatory lesions (open and closed comedones) on the face (including the nose)
- •7. Full comprehension: Subject and parent/guardian for < 18 years old subjects’ ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
- •8. Contraception and fertility (adult women, i.e. = 18 years old; no female patients < 18 years old will be enrolled): Adult women of childbearing potential who have been using and agree to use for all study duration at least one of the following reliable methods of contraception:
- •- Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 6 months before the screening visit
- •- A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
- •- A male sexual partner who agrees to use a male condom with spermicide
- •- A sterile sexual partner
- •9. Female participants of non-childbearing potential will be admitted. For all female subjects, pregnancy test result must be negative at screening
- •Are the trial subjects under 18? yes
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Acne: Patients with spontaneously improving or rapidly deteriorating acne within at least 3 months before screening. Patients who have a known history of acne unresponsive to topical treatments. Patients with generalized or localized severe acne. Acne Conglobata, Acne Fulminans, Acne Rosacea, Secondary Acne (Chloracne, drug-induced acne, etc), Nodule-Cystic Acne, Acne requiring Systemic Treatment.
- •2.Beard and facial hair: Patients who have a beard or who intend to grow a beard during the study. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator
- •3.Skin diseases: Subjects with other active skin diseases (e.g. urticaria, atopic dermatitis) or skin infections (bacterial, fungal, or viral) that might interfere with the evaluation of acne, with the exception of footpad trichophytosis (athlete's foot)
- •4.Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study products. Subjects with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients
- •5.Topical therapies: 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 and retinoids.
- •6.Facial Procedures: 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. Chemical or laser peel, micorderma abrasion, etc ) within the past 4 weeks or during the study
- •7.Phototherapy: 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 have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the trial
- •8.Systemic therapies: 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 subject’s acne (i.e. anabolics, lithium, EGRF inhibitors, iodides)
- •9.Sistemic 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. D) Behçet’s Disease.
- •10.Investigative studies: Participation in the evaluation of any investigational product or device within 6 Months before study baseline
- •11.Diseases: Subject with underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator could significantly immunocompromise the subject and/or place the subject at an unacceptable risk to receiving an immunomodulatory therapy. Any condition which in the investigator’s opinion would make it unsafe for the subject to participate in the study
- •12.Alcohol and other substance abuse: History of alcohol or other substance abuse within one year before
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