Clinical trial NCT03114514: Efficacy of Platelet-rich Plasma (PRP) in the Treatment of Dark Circles Under the Eyes
Official title: Efficacy of Platelet-Rich Plasma (PRP) in the Treatment of Periorbital Hyperpigmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Hyperpigmentation
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Skin Color
timeFrame: 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: Satisfaction
timeFrame: Satisfaction will be measured at three months following the last injection.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Dermatology and Venereology at Damascus University
Study officials:
affiliation: Resident at the Dermatology and venereology Hospital of Damascus university.
name: Raed Sameer Noueihed, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Roh MR, Chung KY. Infraorbital dark circles: definition, causes, and treatment options. Dermatol Surg. 2009 Aug;35(8):1163-71. doi: 10.1111/j.1524-4725.2009.01213.x. Epub 2009 May 15.
citation: Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.
citation: Alsousou J, Ali A, Willett K, Harrison P. The role of platelet-rich plasma in tissue regeneration. Platelets. 2013;24(3):173-82. doi: 10.3109/09537104.2012.684730. Epub 2012 May 30.
citation: Sommeling CE, Heyneman A, Hoeksema H, Verbelen J, Stillaert FB, Monstrey S. The use of platelet-rich plasma in plastic surgery: a systematic review. J Plast Reconstr Aesthet Surg. 2013 Mar;66(3):301-11. doi: 10.1016/j.bjps.2012.11.009. Epub 2012 Dec 11.
citation: Abuaf OK, Yildiz H, Baloglu H, Bilgili ME, Simsek HA, Dogan B. Histologic Evidence of New Collagen Formulation Using Platelet Rich Plasma in Skin Rejuvenation: A Prospective Controlled Clinical Study. Ann Dermatol. 2016 Dec;28(6):718-724. doi: 10.5021/ad.2016.28.6.718. Epub 2016 Nov 23.
citation: Conde Montero E, Fernandez Santos ME, Suarez Fernandez R. Platelet-rich plasma: applications in dermatology. Actas Dermosifiliogr. 2015 Mar;106(2):104-11. doi: 10.1016/j.ad.2013.12.021. Epub 2014 May 1. English, Spanish.