Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH)
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 主要终点
- cure rate
研究概览
简要总结
To evaluate the saftey and efficicacy of autologous PRP in treatment of POH.
详细描述
Periorbital hyperpigmentation (POH) is a common dermatological condition, also known as periorbital melanosis, periocular hyperpigmentation dark circles under the eyes (DC), infraorbital discoloration, infraorbital darkening, or idiopathic cutaneous hyperchromia of the orbital region. It is a common cosmetic condition that occurs in both sexes and may be considered to be normal variants of pigmentation .
Periorbital hyperpigmentation is a multi-factorial entity.The proposed possible causative factors include genetic or heredity, excessive pigmentation, periorbital edema, thin and translucent lower eyelid skin, venous congestion with hemosiderin deposition, orbital structural problem and shadowing due to skin laxity & tear trough. Other factors such as underlying systemic, metabolic, hormonal diseases, nutritional deficiencies, drugs, allergic reactions, atopic dermatitis, sleep disorders, stress, alcohol consumption, smoking, frequent cosmetic use, frequent eye rubbing and lack of correction for errors of refraction like myopia are also implicated to POH .
Periorbital hyperpigmentation is classified according to Ranu et al into five categories based on the causative factors 1. Constitutional type: seen as typical brownish curved band on lower eyelid or both. 2.Postinflammatory type: irregular patches of brown or grey pigmentation associated with features of lichenification.3. Vascular type: erythema or prominent capillaries or telangiectasia. 4. Shadow effect type: tear trough and eye bags due to sagging skin around eyes. 5. Others: anaemia, hormonal disturbances, nutritional deficiencies and chronic illnesses .
Periorbital hyperpigmentation is graded into four groups according to the severity of the case to be treated;
- Grade1: characterized by faint pigmentation of infraorbital region.
- Grade 2: pigmentation is more pronounced.
- Grade3: deep dark color, all four lids involved.
- Grade 4: grade 3 + pigmentation spreading beyond infraorbital fold .
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- ••Both sexes will be included.
- •Age (20-50)
- •Patient with Fitzpatrick skin types III-IV
排除标准
- •• Patients with known platelet dysfunction syndrome, critical thrombocytopenia (<50,000/ul), any hemodynamic instability.
- •Patients with chronic medical illness (e.g. diabetes, chronic infections, and blood dyscrasias).
- •Patients with local inflammatory skin disorders or active herpes infection at the site of the procedure.
- •Patients on consistent use of anti-coagulants or non-steroidal anti-inflammatory drugs (NSAID) within 48 hours of procedure.
- •Haemoglobin level< 10 g/dl were also excluded.
- •Patients with cancer- especially hematopoietic or of bone.
- •Pregnant females.
- •Patients with corticosteroids injection at treatment site within 1 month or systemic use of corticosteroids within 2 weeks.
结局指标
主要结局
cure rate
时间窗: 6 months
assess cure rate of PRP in treatment of POH
次要结局
未报告次要终点
研究者
ARYousef
principal investigator
Assiut University