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

May 13, 2017 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Dermatology and Venereology at Damascus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 61 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Raed Sameer Noueihed, M.D., Resident at the Dermatology and venereology Hospital of Damascus university.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2016

Primary Completion (Actual)

April 20, 2017

Study Completion (Actual)

May 10, 2017

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 13, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDMS-Dermat-01-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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