NCT00469183已完成4 期
An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Safety - Skin biopsy evaluation - histological assessment of skin atrophy
研究概览
简要总结
Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.
详细描述
Same as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a clinical diagnosis of moderate to severe melasma
- •Subjects willing to undergo biopsy four times throughout the study, two biopsies at baseline (one in a melasma involved area and one in a non-involved area). The third and fourth biopsies will be performed at 3 months and 6 months, respectively; in order to avoid variability in histopathological findings,
- •Subjects must have substantial melasma involvement of the cheeks and be willing to have the same general site biopsied at the baseline, month 3 and month 6 visits.
排除标准
- •Subjects with diagnosis of dermal melasma
- •Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
- •Subjects who have used retinoids, steroids, and/or skin lightening products 4 weeks prior to study entry
- •Subjects who show signs of Poikiloderma of Civatte (mandibular hyperpigmentation)
- •Subjects with a history of hypertrophic scarring or a history of keloids
- •Subjects who are unable to avoid the use of a class 1 steroid during their participation in the study
结局指标
主要结局
Safety - Skin biopsy evaluation - histological assessment of skin atrophy
时间窗: Baseline, 12 weeks and 24 weeks
次要结局
- Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment(Baseline, 12 weeks and 24 weeks)
研究者
研究点 (4)
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