Efficacy of Platelet-rich Plasma (PRP) in the Treatment o... | NCT03114514

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

NCT03114514

Sponsor

Damascus University

Status

Completed

Last Update Posted

May 16, 2017Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Periorbital Hyperpigmentation

Interventions

Countries

Syria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2016Actual

Primary Completion Date

Apr 20, 2017Actual

Completion Date

May 10, 2017Actual

First Submitted Date

Apr 11, 2017

First Submission Date that Met QC Criteria

Apr 13, 2017

First Posted Date

Apr 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2017

Last Update Posted Date

May 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRP injection	Experimental	A PRP-injection will be performed three times during the course of treatment	Biological: PRP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRP	Biological	PRP will be injected subcutaneously around the eyes at three different time points with one-month interval	PRP injection

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raed Sameer Noueihed, M.D.	Resident at the Dermatology and venereology Hospital of Damascus university.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology and Venereology at Damascus University		Damascus		DM20AM18	Syria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17760701	Background	Freitag FM, Cestari TF. What causes dark circles under the eyes? J Cosmet Dermatol. 2007 Sep;6(3):211-5. doi: 10.1111/j.1473-2165.2007.00324.x.
24700933	Background	Sheth PB, Shah HA, Dave JN. Periorbital hyperpigmentation: a study of its prevalence, common causative factors and its association with personal habits and other disorders. Indian J Dermatol. 2014 Mar;59(2):151-7. doi: 10.4103/0019-5154.127675.