NCT02095756已完成不适用
A Randomized, Split-Face, Double-Blind Clinical Pilot Study of Combination Picosecond Alexandrite Laser and Non-Hydroquinone Topical Therapy Versus Topical Therapy Alone for the Treatment of Facial Melasma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Melasma clearance
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of a combination of non-hydroquinone topical therapy and a 755nm Alexandrite compared to topical therapy alone for the treatment of facial melasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Subjects aged 18-74 years of age;
- •Fitzpatrick Skin Types I-IV;
- •Female subjects of childbearing potential must have a negative urine pregnancy test at the beginning of the study, and agree to practice appropriate birth-control to prevent pregnancy during the study. The type and dose of birth control must have been stable for at least 3 months prior to study entry and it is not expected to change during the study; acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplant®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active.
- •Subjects diagnosed with moderate to severe melasma on both sides of the face
- •For subjects using medication to treat a concurrent medical condition, type and dose must have been stable for at least 3 months prior to study entry and it is not expected to change during the study (except any medications specifically outlined in the
排除标准
- •Subjects able to avoid prolonged sun exposure on the face for the duration of the study and willing to use appropriate sun avoidance techniques.
- •Subjects able to follow study instructions and likely to complete all required visits;
- •Subjects/Representative able and willing to sign the Informed Consent (which includes a photography release) prior to any study procedures.
- •Exclusion Criteria:
- •Female subjects who are pregnant, nursing or planning a pregnancy during the course of the study;
- •Subjects with a condition or who are in a situation which, in the Investigator's opinion, may put the Subject at risk, may confound the study results, or may interfere with the Subject's participation in the study, such as: the use of a concomitant medication that can interfere with the study or worsen any condition when used during the study, the use of medications known to induce photosensitivity;
- •Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study regimen (e.g. eczema, psoriasis, severe sun-damage, dermatitis) and/or have scarring or infection of the area to be treated;
- •Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma, etc.) in the areas to be treated;
- •Subject unwilling to avoid any other treatment for melasma during the study (total duration of 30 weeks);
- •Subjects with a wash-out period of less than 14 days for melasma treatments at the time of study entry or under current treatment;
- •Subjects with prior facial resurfacing, deep or chemical peels within 6 months of the date of study entry;
- •Subject unwilling to refrain from any facial cosmetic procedures during the study period (e.g., chemical peels, resurfacing, microdermabrasion, etc.);
- •Subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study;
- •Subject has participated in a clinical research study within the last 30 days prior to enrollment;
- •Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or other reasons;
- •Subject is unable to meet the study attendance requirements.
研究组 & 干预措施
755nm Alexandrite laser
Experimental
755nm Alexandrite laser for the treatment of melasma
干预措施: Lytera Skin Brightening System (Non-hydroquinone topical therapy) (Other)
755nm Alexandrite laser
Experimental
755nm Alexandrite laser for the treatment of melasma
干预措施: 755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy) (Other)
结局指标
主要结局
Melasma clearance
时间窗: up to 3 months post last treatment
Evaluate the efficacy of a combination of non-hydroquinone topical therapy and a 755-nm alexandrite laser compared to topical therapy alone in the treatment of melasma .
次要结局
未报告次要终点
研究者
研究点 (1)
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