Efficacy of Platelet-rich Plasma (PRP) in the Treatment of Dark Circles Under the Eyes

Study Overview
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Brief Summary
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10 ml of blood from each patient will be drawn. This blood specimen will be centrifuged in a specific way to get 1 ml of platelet rich plasma (PRP). PRP will be injected into the the skin under the eyes. The treatment course consists of three sessions of PRP injections with one-month intervals between the sessions.

Detailed Description
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Background: Dark circles around the eyes is a common problem pretending with relatively dark eyelids concerns many patients, especially women, because of the inconvenience caused by esthetic and negative impact on the psyche and the patient's quality of life. There are several causing factors (such as sun exposure, smoking, alcohol, sleep deprivation, genetic and structural factors). variety of treatments have been used for this situation , but without clear results. The term 'Platelet-Rich Plasma (PRP)' is a general term used to describe hanging plasma that has been obtained from whole blood with concentration of platelets higher than normal concentration found in the circulating blood. PRP's work mechanism depends on the fact that platelets contain important substances called (growth factors), which have a known role in the process of reform and renewal of tissues. Aim of the research: This study was designed to evaluate the effectiveness of (PRP) injection in the treatment of dark circles under the eyes. This is an uncontrolled open therapeutic trial study which will be performed at the Hospital of Dermatology and Venereology of Damascus University in Damascus, Syria during the period from June 2016 to June 2017. The results will be assessed by standardized digital photography month after each injection and three months after the latest assessment with the assistant of skin colors scale. In addition, the patient's satisfaction with the results and any treatment-related side effects will be recorded.

Official Title
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Efficacy of Platelet-Rich Plasma (PRP) in the Treatment of Periorbital Hyperpigmentation

Conditions
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Periorbital Hyperpigmentation

Intervention / Treatment
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* Biological: PRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with periorbital hyperpigmentation Exclusion Criteria: patients with known platelet dysfunction syndrome patients with platelet count less than 100,000 ul patient with hemodynamic instability patients with severe systemic illness or malignancy or chronic medical illness (e.g. diabetes, chronic infections, and blood dyscrasias). patients with local skin disorders or active herpes infection at the site of the procedure. patients on anti-coagulants therapy or non-steroidal anti-inflammatory drugs (NSAID) within 48 hours of procedure, patients with corticosteroid injection at treatment site within 1 month, systemic use of corticosteroids within 2 weeks patients with recent fever or illness, and hemoglobin level< 10 g/dl. pregnancy history of keloidal scarring.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP injection<br>A PRP-injection will be performed three times during the course of treatment | Biological: PRP<br>* PRP will be injected subcutaneously around the eyes at three different time points with one-month interval<br>* Other names: platelet-rich plasma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin Color | Standardized digital photographs will be taken and a color scale will be used | Color shade will be measured at one month following the first injection (T1) and at three months following the third injection (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction | Patients' satisfaction will be measured on a visual analog scale (VAS) | Satisfaction will be measured at three months following the last injection. |