A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change from Baseline in Melasma Area and Severity Index (MASI) at 12 weeks after final treatment
研究概览
简要总结
In several observational studies, non-ablative fractional photothermolysis (FP) has been reported to bridge the gap between efficacy and tolerability in the treatment of melasma. While some beneficial effects have been attributed to non-ablative FP in treating melasma, methodological constraints (e.g., a limited number of patients; no control group assignment) impair efficacy assessment; currently published results neither allow researchers and clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular, bias resulting from poorly designed trials may mislead clinicians into making a wrong decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and safety of FP in the treatment of melasma as compared to the lone application of a sun-blocking lotion (SPF >50).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (female/male) with clinical evidence of melasma;
- •Fitzpatrick skin phototype I-III;
- •Ability and willingness to comply with the requirements of the protocol.
排除标准
- •Pregnancy or nursing;
- •Inability to avoid sun exposure for occupational reasons (e.g., gardeners);
- •Known history or clinically relevant allergy to components of the sunscreen or topical anaesthetic;
- •Use of topical retinoids within 3 months prior to study enrolment;
- •Use of topical hydroquinone within 6 months prior to study enrolment;
- •Use of topical corticosteroids within 1 month prior to study enrolment;
- •Use of topical cosmetic depigmenting agents within 2 weeks prior to study enrolment;
- •Laser surgery procedures within the treatment region during the last 12 weeks prior to enrolment;
- •Coagulation disorders or anticoagulant treatment;
- •Photo-sensitizing medication (e.g., tetracyclines, gold).
结局指标
主要结局
Change from Baseline in Melasma Area and Severity Index (MASI) at 12 weeks after final treatment
时间窗: Pre-treatment and at final follow-up (12 weeks after last treatment session)
次要结局
- Subjective assessment of treatment outcome (by patients)(Pre-treatment and at final follow-up)
- Patient satisfaction(Pre-treatment and at final follow-up)
- Side effects(At each follow-up visit (week 3, 6, 9, 12))