EUCTR2014-002509-39-GB进行中（未招募）1 期
Effect of Patient Education on Treatment Adherence and Satisfaction among Acne Patients Receiving Once-Daily EpiduoTM Gel Treatment in Primary Care Clinics - PEAce (Patient Education on Acne)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GALDERMA R&D
- 入组人数
- 97
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
入选标准
- •1.Male or female subjects age of 12 years or older,
- •2.With facial acne vulgaris that can be managed in primary care,
- •3.Female subjects of childbearing potential with a negative urine pregnancy test (UPT) at Baseline visit,
- •4.Female subjects of childbearing potential must practice a highly effective method of contraception during the study: medical contraception (combined oral contraceptives [estrogens and progesterone] or implanted or injectable contraceptives with stable dose for at least 1 month prior to study entry), bilateral tubal ligation, hormonal intrauterine device (inserted at least 1 month prior to study entry), strict abstinence (at least 1 month prior to study entry and agree to continue for the duration of the study), or vasectomized partner (at least 3 months prior to study entry),
- •5.Females of non-childbearing potential, e.g., premenses, post-menopausal (absence of menstrual bleeding for 1 year prior to study entry), hysterectomy, or bilateral ovariectomy,
- •6.Subjects willing and capable of complying with the extent and degree required by the protocol,
- •7.Subjects or the parents/legal guardians (for subjects of 12-17 years old) understand and sign the Informed Consent Form (ICF) at Baseline, prior to any investigational procedure being performed.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Female subjects who are pregnant, nursing or planning a pregnancy during the study,
- •2.Subjects have acne on their chest and/or back,
- •3.Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans),
- •4.Subjects with severe acne or painful, deep nodules or cysts (nodulocystic acne),
- •5.Subjects with severe social or psychological problems including a morbid fear of deformity (dysmorphophobia),
- •6.Subjects are at risk of, or are developing, scarring despite primary care therapies,
- •7.Subjects have moderate acne that has failed to respond to treatment which should generally include several courses of both topical and systemic treatment over a period of at least 6 months,
- •8.Subjects are suspected of having an underlying endocrinological cause for the acne (such as polycystic ovary syndrome) that needs assessment,
- •9.Subjects currently taking any other acne treatments,
- •10.Subjects with known impaired hepatic or renal functions
- •11.Subjects with known intolerance to lactose,
- •12.Subjects with a condition or who are in a situation which, in the investigator’s opinion, may put the subject at risk, confound the study results, or interfere with the subject’s participation in the study,
- •13.Subjects who are at risk in terms of precautions, warnings, and contraindications (see package inserts),
- •14.Subjects with known or suspected allergies or sensitivities to any component of the study drug (see package inserts),
- •15.Subjects who have participated in another investigational drug or device research study within 30 days of enrolment of this study,
- •16.Subjects of 12-17 years for whom the signed ICF from their parents/legal guardians is not obtained,
- •17.Subjects under guardianship, hospitalised subjects in a public or private institution for a reason other than the research, and subjects deprived of their freedom
研究者
相似试验
招募中
不适用
Effect of Patient Education on Medication Adherence in Patient with Rheumatoid Arthritis: A randomized controlled trialMedication adherenceRheumatoid arthritisTCTR20171207003Phramongkutklao Hospital114
已完成
不适用
Effect of patient education on adherence to antiretroviral therapy and its clinical outcomes among human immunodeficiency virus patients in Jos university teaching hospital, NigeriaHIV/AIDSPACTR201811482580522Panmial Priscilla Damulak224
已完成
不适用
Effect of peer education on treatment adherence and quality of life in Coronary Artery Bypass Graft (CABG) patientsAtherosclerotic heart disease.Atherosclerotic heart diseaseIRCT2017060623670N2Research Deputy of Arak University of Medical Sciences70
已完成
不适用
The effect of patient education on compliance with drug therapy for rheumatoid arthritisMusculoskeletal DiseasesOther rheumatoid arthritisRheumatoid arthritisISRCTN68585617Arthritis Research Campaign (ARC) (UK)
已完成
4 期
Patient Education in Adherence on Acne (PEAce)AcneNCT02307266Galderma R&D97