NCT02791243已完成1 期
A Within-subject, Randomized, Evaluator-blinded, Vehicle-controlled Study to Assess the Photosensitization Potential of Finasteride Cutaneous Solution(P-3074) in Human Subjects
Polichem S.A.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年5月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Potential for induction of photosensitization
研究概览
简要总结
This study evaluates the potential for induction of photosensitization by P-3074 0.25% finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a negative control (0.9% sodium chloride, NaCl)
详细描述
Healthy male volunteers, drawn from the general population, will be treated with P-3074 solution, placebo vehicle control and 0.9% sodium chloride USP (negative control) by using 6 induction applications on the back area and Ultraviolet A (UVA)/Ultraviolet B (UVB) irradiations during the 3 week induction period, a 10 day rest period, and a challenge phase of a 24-hour patch application, UVA and UVB irradiation followed by evaluation of photosensitization over the subsequent 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 18 to
- •Good general health, as assessed by verbal medical history and brief physical examination of the skin.
- •Fitzpatrick Skin Type I-IV, determined by interview at screening.
- •Willing to use a double-barrier methods (for example, a condom or a diaphragm plus spermicide) during sexual intercourse with a female partner while participating in the study.
- •Male subjects will need to confirm method and length of time for method of birth control for female partners.
- •Fully informed of the risks of entering the study and willing to provide written consent to enter the study.
- •Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
- •Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating on the study.
排除标准
- •MED ≤ 2.5 SED for Fitzpatrick Skin Types I and II or MED ≤ 4.0 SED for Fitzpatrick Skin Types III and IV
- •Type I Insulin-dependent diabetes
- •Mastectomy for cancer involving removal of lymph nodes draining the test site.
- •Clinically significant skin diseases which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active skin cancer.
- •Use of any photosensitizing medications or supplements, such as but not limited to sulfa drugs, tetracyclines, phenothiazines, thiazides, antiemetics and St. John's Wort.
- •Any medical conditions caused or affected by sunlight (UV), such as but not limited to solar urticarial and polymorphous light eruptions.
- •Active immunologic disorders.
- •Routine use of anti-inflammatory, immunosuppressive or antihistamine medications (81 mg aspirin is acceptable).
- •Participation in a patch test or soap chamber test within the past 4 weeks.
- •History of significant sensitivity or allergy to adhesive bandages, tapes, etc.
- •Use of finasteride (oral and/or topical), within 6 months prior to the screening visit.
- •Contraindications to finasteride therapy or intolerance of finasteride.
- •History of sensitivity to skin solution products.
- •Hair, tattoos, pigmentation, scars, moles or other conditions at the areas to be patched that may interfere with patch application, tolerability, or postapplication evaluations.
- •Participation in a clinical trial or receipt of an investigational medication within 4 weeks of the study.
- •Current treatment with allergy injections.
- •History of severe asthma.
- •Chronic or active liver disease [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5x upper limit of normal (ULN)]
- •Neutrophils < 1500 cells/mm3
- •Clinically significant chronic illness, which could place the subject at increased risk during participation or result in inappropriate dermal response during the study in the opinion of the Investigator.
- •History of alcohol or drug abuse within 1 year of the study.
- •Any condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk.
- •Judged by the investigator to be unsuitable for any reason.
研究组 & 干预措施
Placebo for Finasteride 0.25%
Placebo Comparator
approximately 0.2 ml of the vehicle cutaneous solution
干预措施: Placebo for Finasteride 0.25% (Drug)
Negative Control
Other
approximately 0.2 ml of 0.9% aqueous NaCl
干预措施: Negative Control (Drug)
Finasteride 0.25%
Experimental
approximately 0.2 ml of P-3074 (0.25% finasteride)
干预措施: Finasteride 0.25% (Drug)
结局指标
主要结局
Potential for induction of photosensitization
时间窗: from day 4 to day 42
次要结局
未报告次要终点
研究者
研究点 (1)
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