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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

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date May 16, 2017
Actual Study Start Date  ICMJE June 17, 2016
Actual Primary Completion Date April 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Platelet-rich Plasma (PRP) in the Treatment of Dark Circles Under the Eyes
Official Title  ICMJE Efficacy of Platelet-Rich Plasma (PRP) in the Treatment of Periorbital Hyperpigmentation
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Periorbital Hyperpigmentation
Intervention  ICMJE Biological: PRP
PRP will be injected subcutaneously around the eyes at three different time points with one-month interval
Other Name: platelet-rich plasma
Study Arms  ICMJE Experimental: PRP injection
A PRP-injection will be performed three times during the course of treatment
Intervention: Biological: PRP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 10, 2017
Actual Primary Completion Date April 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Syrian Arab Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03114514
Other Study ID Numbers  ICMJE UDMS-Dermat-01-2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Damascus University
Study Sponsor  ICMJE Damascus University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raed Sameer Noueihed, M.D. Resident at the Dermatology and venereology Hospital of Damascus university.
PRS Account Damascus University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP