NCT01254162已完成2 期
A 4-Week, Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate the Potential of Topically Applied 0.75% (w/w) MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
Mimetica Pty Limited1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- A 20% reduction in sebum production as measured by the Sebumeter
研究概览
简要总结
To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum production on the forehead of healthy male volunteers.
详细描述
This is a single-center, randomized, double-blind, placebo-controlled proof-of-concept study of the investigational product (0.75% (w/w) MTC896 Gel) compared to a placebo control. Subjects will be randomized to 1 of 2 treatment groups, 0.75% (w/w) MTC896 Gel or Placebo. Approximately 134 subjects will be enrolled to yield 60 completed subjects in each group. One group will receive once daily topical applications of 0.75% (w/w) MTC896 Gel to the forehead for 28 consecutive days, and the other will receive placebo under the identical regimen. Enrollment will be staggered to allow monitoring of safety and tolerability. A lead cohort will include approximately 20 subjects (10 in the MTC896 Group and 10 in the Placebo Group). Application on additional subjects will not be initiated until the lead cohort has completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Are healthy males;
- •Are between 18 and 65 years of age;
- •Have self-perceived oily skin confirmed by a clinical assessment;
- •Have an average Sebumeter® reading of ≥ 220 µg/cm2 on the forehead;
- •Have a negative urine drug screening test result;
- •Have a negative HIV and hepatitis screening test result;
- •Agree to use adequate contraceptive precautions (ie, use of condoms) during the conduct of the study;
- •Have a body mass index (BMI) of 19 to 34 kg/m2;
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- •Are willing to abstain from using any facial treatment products or personal care products (moisturizer, sunscreen, hair spray, etc) on the forehead during the study;
- •Are willing to avoid sun exposure and to protect the forehead with a hat/visor;
- •Are fluent in the English language;
- •Complete a standard Medical Screening form as well as a Medical Personal History form; and
- •Read, understand, and provide a signed informed consent.
排除标准
- •Have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the study evaluations;
- •Have a history of photosensitive reactions or a history of cutaneous or systemic lupus or other disorders frequently associated with photosensitivity;
- •Are not willing to refrain from using systemic/topical analgesics such as aspirin (81 mg daily aspirin will be allowed at the discretion of the PI), Aleve, Motrin, Advil, or Nuprin for 24 hours prior to and during the study (use of acetaminophen will be permitted);
- •Are using systemic/topical corticosteroids in the test area for 3 weeks prior to and during the study, or systemic/ antihistamines for 24 hours prior to and during the study;
- •Are using topical retinoids, products containing benzoyl peroxide, salicylic acid, or alpha-hydroxy acids for 2 weeks prior to and during the study; or systemic retinoids within 3 months prior;
- •Are using any medication which, in the opinion of the investigator, will interfere with the study evaluations;
- •Have seborrheic dermatitis and/or active atopic dermatitis/eczema in or around the test sites;
- •Have a known allergy and/or hypersensitivity to constituents present in the study products;
- •Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
- •Have received treatment for any type of internal cancer within 5 years prior to study enrollment;
- •Have a history of, or are currently being treated for skin cancer;
- •Are currently participating in any clinical testing; and/or
- •Have received any investigational treatment(s) within 4 weeks prior to study enrollment.
研究组 & 干预措施
Placebo Gel
Experimental
干预措施: MTC896 Gel (Drug)
结局指标
主要结局
A 20% reduction in sebum production as measured by the Sebumeter
时间窗: 28 days
次要结局
- Assess the safety and tolerability of the product when applied daily to the forehead for 28 days(28 days)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
A Study to Determine the Efficacy of Topically Applied MTC896 Gel in Subjects With Acne VulgarisAcne VulgarisNCT02395549Mimetica Pty Limited364
已完成
1 期
Pharmacokinetic Study of MTC896 Gel in Subjects With AcneAcne VulgarisNCT02293018Mimetica Pty Limited32
撤回
2 期
TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne VulgarisAcne VulgarisNCT02796066Thesan Pharmaceuticals, Inc.
已完成
2 期
A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in AdultsLateral Canthal LinesCrow's FeetFacial WrinklesNCT01124552Revance Therapeutics, Inc.180
已完成
2 期
Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)Erectile DysfunctionNCT02495467Futura Medical Developments Ltd.232