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Completed

NCT Number: NCT03114514

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

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.

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology and Venereology at Damascus University

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRP

Biological

PRP will be injected subcutaneously around the eyes at three different time points with one-month interval

Other names: platelet-rich plasma

Primary outcomes

  1. Change in Skin Color

    Time frame: Color shade will be measured at one month following the first injection (T1) and at three months following the third injection (T2)

    Standardized digital photographs will be taken and a color scale will be used

Secondary outcomes

  1. Satisfaction

    Time frame: Satisfaction will be measured at three months following the last injection.

    Patients' satisfaction will be measured on a visual analog scale (VAS)

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2017
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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