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

NCT03114514 | Completed DMC

• 1 other identifier: UDMS-Dermat-01-2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periorbital Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Satisfaction

  Satisfaction will be measured at three months following the last injection.

Study Arms (1)

PRP injection

EXPERIMENTAL

A PRP-injection will be performed three times during the course of treatment

Biological: PRP

Interventions

PRP BIOLOGICAL

PRP will be injected subcutaneously around the eyes at three different time points with one-month interval

Also known as: platelet-rich plasma

PRP injection

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with periorbital hyperpigmentation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Dermatology and Venereology at Damascus University

Damascus, DM20AM18, Syria

Location

Related Publications (8)

• 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.

  PMID: 17760701 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.

  PMID: 24700933 BACKGROUND

• 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.

  PMID: 19469797 BACKGROUND

• 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.

  PMID: 19187989 BACKGROUND

• 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.

  PMID: 22647081 BACKGROUND

• 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.

  PMID: 23238115 BACKGROUND

• 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.

  PMID: 27904271 BACKGROUND

• 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.

  PMID: 24795093 BACKGROUND

Study Officials

• Raed Sameer Noueihed, M.D.

  Resident at the Dermatology and venereology Hospital of Damascus university.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: June 17, 2016
• Primary Completion: April 20, 2017
• Study Completion: May 10, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)