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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114514
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periorbital Hyperpigmentation Biological: PRP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Platelet-Rich Plasma (PRP) in the Treatment of Periorbital Hyperpigmentation
Actual Study Start Date : June 17, 2016
Actual Primary Completion Date : April 20, 2017
Actual Study Completion Date : May 10, 2017

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 Name: platelet-rich plasma




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114514


Locations
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Syrian Arab Republic
Department of Dermatology and Venereology at Damascus University
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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Principal Investigator: Raed Sameer Noueihed, M.D. Resident at the Dermatology and venereology Hospital of Damascus university.

Publications:

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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03114514    
Other Study ID Numbers: UDMS-Dermat-01-2017
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases