Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in the Treatment of Melasma: A Split Face Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hemi-Melasma Area and Severity Index (MASI) score
研究概览
简要总结
Melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. Melasma is considered a disappointing challenge when treatment options are addressed. Diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels, microdermabrasion, and lasers have been tried for the treatment of melasma. There is no universally proven therapy that induces and maintains remission of the condition. Q-switched: Nd YAG laser toning and platelet rich plasma (PRP) are promising treatments for melasma.The aim of this work is evaluate the efficacy and safety of combined PRP and Q-switched: NdYAG laser in the treatment of melasma using clinical assessment, in addition to assessment of Melanin Index and Erythema Index.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral nearly symmetric melasma on the face.
排除标准
- •Patients receiving systemic or topical or laser treatment relevant to melasma within three months before enrollment into the study.
- •Use of oral or injectable contraceptives or hormone replacement therapy during treatment or 12 months before
- •Patients active skin infections and active HSV
- •History of hypertrophic scars or keloids.
- •Patients with hypercoagulable state or bleeding diatheses
- •Pregnant and lactating females.
- •History of liver diseases
- •Intake of systemic chemotherapy, corticosteroids, antiplatelets or anticoagulants
结局指标
主要结局
Hemi-Melasma Area and Severity Index (MASI) score
时间窗: 2 months after final treatment
Hemi-Melasma Area and Severity Index(MASI) score for Pigmentation, and Area of involvement. The minimum value is 0 and the maximum value is 12. Higher scores mean a worse outcome.
次要结局
- Melanin Index(2 months after final treatment)
- Erythema Index(2 months after final treatment)
研究者
Mona El-Kalioby
Principal Investigator
Cairo University