Trichloroacetic Acid (TCA) Combined With Microdermabrasion in Treatment of Melasma
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- "EFFICACY of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma "
研究概览
简要总结
- To detect the efficacy and safety of combined TCA and MDA in treating melasma.
- To compare the efficacy and safety of using different TCA concentrations (15% & 20%) alone and in combination with MDA in treatment of melasma.
详细描述
Melasma is a common, acquired hypermelanosis that occurs in sun exposed areas, mostly on the face, occasionally on the neck, and rarely on the forearms.
Melasma is generally a clinical diagnosis consisting of symmetric reticulated hypermelanosis in three predominant facial patterns: Centro facial, malar, and mandibular The major clinical pattern in 50-80% of cases is the Centro facial pattern, which affects the forehead, nose, and upper lip .
The malar pattern is restricted to the malar cheeks on the face, while mandibular melasma is present on the jawline and chin .
A newer pattern termed extra-facial melasma can occur on non-facial body parts, including the neck, sternum, forearms, and upper extremities .
Using the Wood's light examination, melasma can be classified into four major histological types depending upon the depth of pigment deposition:The epidermal type, in which the pigmentation is intensified under Wood's light, is the most common type. The epidermal type is the most responsive to treatment.
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
- None
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
- •Adults of 18 years and above with bilateral melasma
- •Clinical diagnosis of melasma.
- •Mental capacity to give informed consent.
排除标准
- •Pregnant or nursing women
- •Current use of hormonal birth control medication or any hormonal therapy
- •History of laser or dermabrasion to the face within 9 months of study enrollment
- •Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids
- •Photosensitivity.
- •Patients with unrealistic expectations All the included patients will be subjected to detailed history taking,dermatological examination and Wood's light examination to estimate the depth (epidermal, dermal or mixed) of melasma.
研究组 & 干预措施
Group 15% concentration
30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face.
干预措施: TCA (Drug)
Group 20 % concentration
30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face.
干预措施: TCA (Drug)
结局指标
主要结局
"EFFICACY of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma "
时间窗: 3 months
To detect the efficacy of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma. Clinical photographs: Front, right and left views of face of each patient will be photographed at baseline, every two weeks and one month after the last session with and high resolution digital camera in natural light.
次要结局
未报告次要终点
研究者
Amira Ahmed Mohamed
Principle investigator
Assiut University