Split-Face, Randomized, Open-Label Study of Sequential Treatment With Tri-Luma® Cream With Intense Pulsed Light (IPL) vs. a Mild Inactive Control Cream With Intense Pulsed Light (IPL) in Subjects With Melasma
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Galderma R&D
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma
研究概览
简要总结
This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period.
详细描述
Same as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Subjects diagnosed with moderate to severe melasma on both sides of the face (Investigator's Global Assessment (IGA) at baseline must be 3 or 4.)
排除标准
- •Subjects with a diagnosis of skin cancer (Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC), Melanoma) in the areas to be treated
- •Subjects with prior facial Intense Pulsed Light (IPL), resurfacing, deep or chemical peels within 6 months of the date of study entry
- •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
研究组 & 干预措施
IPL / Tri-Luma® Cream
干预措施: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% (Drug)
IPL/Cetaphil® Moisturizing Cream as Inactive Control
干预措施: Cetaphil® Moisturizing Cream as Inactive Control (Drug)
结局指标
主要结局
Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma
时间窗: Baseline to week 10
Number of participants who were a success or failure with regards to melasma severity at Week 10 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure
次要结局
- Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure(Baseline to week 6)
- Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10(Baseline to Week 6 and Baseline to Week 10)
- Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement(Baseline to week 6)
- Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement(Baseline to week 6)
- Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement(Baseline to week 10)
- Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement(Baseline to week 10)
- Number of Participants With Tolerability Assessments Resulting in Adverse Events(Baseline to week 10)