EUCTR2006-004346-17-GB进行中（未招募）不适用
Phase IIB Dose Response and Safety Study of Topical Formulationsof Methotrexate (MQX-5902, MQX-5904 and MQX-5906)in the Treatment of Fingernail Psoriasis - MQT Nail
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 83
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. Outpatients, 18 years to 75 years of age, of any race and of either sex.
- •2. Patients must be in good general health, as assessed by the clinical study investigator.
- •3. Patients must present with clinically diagnosed stable or exacerbating fingernail psoriasis of at least two fingernails (one of which is chosen as the target nail” and one of which is chosen as the control nail”), at the Screening Visit. The patient must have a diagnosis of psoriasis in any area but not palms and soles only.
- •4. Patients must have moderate, not mild or severe, nail psoriasis of at least 2 fingernails. This evaluation is based on standard reference photographs provided by the sponsor that denote the range of nail psoriasis severity termed moderate for this study.
- •5. Patients must sign a statement of informed consent.
- •6. Patients must be able to understand the requirements of the study, abide by the
- •restrictions, apply the study medication as instructed, and return for all of the required clinic visits.
- •7. Female patients must be post-menopausal for at least five years, or have had a
- •hysterectomy, or have had a tubal ligation, or agree to use oral/systemic contraceptives or an intrauterine device (IUD) starting at least 28 days Visit 1, or agree to use a spermicide in combination with barrier methods of contraception. Male patients must agree to use a spermicide in combination with barrier methods of contraception. Contraceptive methods must be continued throughout the study and for at least 3 months after treatment has finished.
- •8. Female patients who are not at least 5 years post-menopausal or surgically sterile must have had a normal menstrual flow within approximately one month prior to Visit 1, and have a negative urine pregnancy test within 7 days prior to Visit 1. Results must be available prior to the first application of test medication. Note: urine pregnancy tests must be performed at each clinic visit.
- •(Note: urine pregnancy tests must be performed at each clinic visit.)
- •9. Patients’ psoriasis therapies must have been stable and unchanged for 2 months prior to the screening visit. Patients must not have received methotrexate for 3 months prior to the screening visit. Patients must agree to apply any non-study topical psoriasis medications used during the course of the study while wearing vinyl gloves and to not apply any of these topical medications to the distal phalanx.
- •Are the trial subjects under 18? no
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with fingernail infections of fungal or bacterial origin, by clinical impression (microbiological confirmation not required).
- •2. Patients for whom the target or control fingernail is thicker than 2 mm.
- •3. Patients with other abnormalities of the target fingernail that could prevent obtaining a normal appearing nail if clearing of psoriasis is achieved (i.e., chemical damage, tumors, genetic disorders affecting the nail, pigmentation disorders).
- •4. Patients with any disease/condition that might cause nail abnormalities or might interfere with the evaluation of the test materials (i.e., open sores on the affected finger, a history of nail biting, nail infections, lichen planus, peripheral vascular disease, and traumatic onychodystrophy due to chronic physical stimuli).
- •5. Patients who have a history of immunosuppression and/or clinical signs indicative of possible immunsuppression, according to the clinical investigator.
- •6. Patients with neuropathies of the hand
- •7. Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal if they are considered by the investigator to be clinically significant or indicative of conditions that might complicate interpretation of study results.
- •8. Patients who are nursing, who are pregnant (confirmation by pregnancy testing) or who plan to become pregnant or father a child within the study time frame, including within three months of last scheduled dose of study medication.
- •9. Patients known to be HIV positive (HIV testing is not required).
- •10. Patients who have abused alcohol or drugs in the 12 months prior to screening or who currently are known to abuse alcohol or drugs.
- •11. Patients with known hypersensitivity to any components of the test materials.
- •12. Patients requiring or using other methotrexate preparations (by any route), or non-study topical anti-psoriatic medications to the distal phalanx, or ultraviolet treatment within 2 months of commencement of study treatment (Visit 1).
- •13. Patients who have used more than one 2-week course of oral corticosteroid therapy or one intramuscular corticosteroid injection during the three months prior to the screening visit.
- •14. Patients who use manicures, any nail polish products or other nail cosmetic products on the target or control fingernail within 7 days prior to the start of treatment. (Patients must agree not to use manicures, nail polish or nail cosmetic products during the study.)
- •15. Patient who have received any investigational drugs or devices or who have participated in any investigational drug/device study within 28 days prior to the start of treatment.
- •16. Patients who require or have had within 90 days of the start of treatment any drug known
- •to have a well-defined potential for toxicity to a major organ (i.e., chloramphenicol).
- •17. Patients with a history of poor cooperation, non-compliance with medical treatment, or unreliability.
- •(Note: In determining the length of washout, the last day therapy was used
- •should be counted as Day 0.)
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