EUCTR2016-003197-41-DE进行中（未招募）1 期
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea over 16 weeks - Efficacy, Safety and Tolerability of DFD-29 Capsules in Rosacea Patients
Dr. Reddy's Labaratories Ltd.0 个研究点目标入组 205 人开始时间: 2016年10月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 205
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.Subjects must be able to understand the requirements of the study and be willing to give written informed consent.
- •2.Male and female subjects aged 18 years and above.
- •3.Subjects, any gender or ethnicity (and of Fitzpatrick skin type I – III), must be in good general health as determined by the Investigator.
- •4.Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 4.
- •5.Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face.
- •6.Subjects must have not more than 2 nodules.
- •7.Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA scale.
- •8.Subjects must agree to only use the study products and to not use any other treatment for rosacea (prescription or Over The Counter (OTC)) during the course of the study.
- •9.Subjects must be free of any systemic or dermatologic disorder, which in the opinion of the Investigator, will interfere with the study results, and especially free of any skin diseases (for example peri-oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne vulgaris) that may confound the evaluation of rosacea.
- •10.Females must have a negative urine pregnancy test at the Screening and Baseline Visit. Sensitivity of such a test should at least be 25 mIU/mL or lower for hCG.
- •11.Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective method of contraception with a pearl index of <1% up to 1 month after last dose. Contraception methods with low user dependency should preferably be used, in particular when contraception is introduced as a result of participation in this clinical study.
- •‘Highly effective’ methods of birth control include:
- •combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation*:
- •ointravaginal
- •otransdermal
- •progesterone-only hormonal contraception associated with inhibition of ovulation*:
- •oinjectable
- •oimplantable†
- •intra-uterine device (IUD) †
- •intra-uterine hormone releasing system (IUS) †
- •bilateral tubular occlusion†
- •vasectomy of sexual partner that was performed at least 90 days prior to Baseline, and has been medically assessed as successful†
- •sexual abstinence
- •oNote: Sexually inactive female subjects may be enrolled at the investigator’s discretion provided that they are counseled to refrain from heterosexual intercourse for the duration of the study and for one month after the last dose, and understand the possible risks involved in getting pregnant during the study.
- •*Hormonal methods: If on hormonal contraceptives, must have been on the same hormonal contraceptive product for 3 months (90 days) prior to Baseline and continued on same method and dose throughout the duration of the study. If subject had used hormonal birth control and had stopped, this should have occurred more than 6 months prior to Baseline. Female subjects on low dose oral contraceptives (containing =35 µg of ethinyl estradiol or equivalent dose of other estrogens) must use a second form of contraceptive during the study.
- •† Contraception methods that are considered to have low user dependency.
- •12.Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and p
排除标准
- •1.Females who are pregnant or nursing or planning to become pregnant during the study.
- •2.Male whose female partner is planning to conceive a child.
- •3.Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).
- •4.Subjects who have been treated with systemic retinoids within 6 months prior to the Baseline visit.
- •5.Subjects who have participated in a trial involving any investigational product in the 90 days prior to the Baseline Visit.
- •6.Subjects with any disease or medical condition that would interfere with the study outcome or place the subject at undue risk.
- •7.Subjects who use or have used systemic steroids within the 30 days prior to the Baseline Visit or any other immunosuppressive medication.
- •8.Subjects who are on anti-coagulants or those who are likely to require anti-coagulants during the study period.
- •9.Subjects who have used methoxyflurane or other nephrotoxic drugs (as judged by the investigator) within the past 30 days.
- •10.Subjects with known hypersensitivity to minocycline or doxycycline or any component of the study products or against other kinds of tetracyclines.
- •11.Subjects with clinically significant abnormal laboratory test that, in the opinion of the investigator, would compromise the subject’s safety or ability to participate in the trial.
- •12.Subjects who are unable to comply with study requirements.
- •13.History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
- •14.Subjects who in the opinion of the investigator or physician performing the initial examination, should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent.
- •15.Subjects with close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial sites or subjects who are an employee of the sponsor.
- •16.Subjects institutionalized because of legal or regulatory order.
- •17.History of drug or alcohol abuse in the last year.
研究者
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