Periorbital HyperpigmentationNCT03114514
Efficacy of Platelet-rich Plasma (PRP) in the Treatment of Dark Circles Under the Eyes
A study testing PRP in people with Periorbital Hyperpigmentation, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Periorbital Hyperpigmentation
- What is being tested?
- PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSyria
- Study dates
- 17 Jun 2016to 10 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with periorbital hyperpigmentation
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Dermatology and Venereology at Damascus University
Damascus, DM20AM18
About this study
Official title: Efficacy of Platelet-Rich Plasma (PRP) in the Treatment of Periorbital Hyperpigmentation
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.
Read the 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.
- Conditions
- Periorbital Hyperpigmentation
- Being tested
- PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Also called platelet-rich plasma
PRP will be injected subcutaneously around the eyes at three different time points with one-month interval
| Study group | Role | What they receive |
|---|---|---|
| PRP injection | Experimental | A PRP-injection will be performed three times during the course of treatment Receives: Biological: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Color
Standardized digital photographs will be taken and a color scale will be used
Measured: 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
Patients' satisfaction will be measured on a visual analog scale (VAS)
Measured: Satisfaction will be measured at three months following the last injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start17 Jun 2016
- Primary completion20 Apr 2017
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Periorbital HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raed Sameer Noueihed, M.D., Principal investigator, Resident at the Dermatology and venereology Hospital of Damascus university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114514
- Sponsor's protocol ID
- UDMS-Dermat-01-2017
- Status last verified
- May 2017
- First submitted
- 11 Apr 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17760701Sheth 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.
PubMed 24700933Roh 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.
PubMed 19469797Dohan 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.
PubMed 19187989Alsousou 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.
PubMed 22647081Sommeling 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.
PubMed 23238115Abuaf 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.
PubMed 27904271Conde 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.
PubMed 24795093
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-Rich Plasma (PRP) in the Treatment of Periorbital Hyperpigmentation
- ClinicalTrials.gov ID
- NCT03114514
- Acronym / sponsor ID
- UDMS-Dermat-01-2017
- Conditions
- Periorbital Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 17 Jun 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP injection | Experimental | Biological: PRPA PRP-injection will be performed three times during the course of treatment |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with periorbital hyperpigmentation
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRPAlso: platelet-rich plasmaPRP will be injected subcutaneously around the eyes at three different time points with one-month interval | Biological | PRP injection |
Primary outcome
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
1 secondary outcome
Satisfaction
Time frame: Satisfaction will be measured at three months following the last injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Background: PubMed 17760701Freitag 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.
- Background: PubMed 24700933Sheth 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.
- Background: PubMed 19469797Roh 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.
- Background: PubMed 19187989Dohan 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.
- Background: PubMed 22647081Alsousou 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.
- Background: PubMed 23238115Sommeling 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.
- Background: PubMed 27904271Abuaf 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.
- Background: PubMed 24795093Conde 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.
- Individual participant dataSharing planned: No
Related trials for Periorbital Hyperpigmentation
Active, not recruiting
Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea
Melasma, Rosacea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raed Sameer Noueihed, M.D. principal investigator
Resident at the Dermatology and venereology Hospital of Damascus university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP in people with Periorbital Hyperpigmentation, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114514, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.