Periorbital HypermelanosisPhase 3NCT03862118
Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH)
A Phase 3 study testing PRP in people with Periorbital Hypermelanosis, run by Assiut University.
Trial summary
To evaluate the saftey and efficicacy of autologous PRP in treatment of POH. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Periorbital Hypermelanosis
- What is being tested?
- PRP
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2020
- Phase
- Phase 3
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- •Both sexes will be included.
- Age (20-50)
- Patient with Fitzpatrick skin types III-IV
Who cannot join
- • Patients with known platelet dysfunction syndrome, critical thrombocytopenia (<50,000/ul), any hemodynamic instability.
- Patients with chronic medical illness (e.g. diabetes, chronic infections, and blood dyscrasias).
- Patients with local inflammatory skin disorders or active herpes infection at the site of the procedure.
- Patients on consistent use of anti-coagulants or non-steroidal anti-inflammatory drugs (NSAID) within 48 hours of procedure.
- Haemoglobin level< 10 g/dl were also excluded.
- Patients with cancer- especially hematopoietic or of bone.
- Pregnant females.
- Patients with corticosteroids injection at treatment site within 1 month or systemic use of corticosteroids within 2 weeks.
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the saftey and efficicacy of autologous PRP in treatment of POH.
Read the detailed description
Periorbital hyperpigmentation (POH) is a common dermatological condition, also known as periorbital melanosis, periocular hyperpigmentation dark circles under the eyes (DC), infraorbital discoloration, infraorbital darkening, or idiopathic cutaneous hyperchromia of the orbital region. It is a common cosmetic condition that occurs in both sexes and may be considered to be normal variants of pigmentation .
Periorbital hyperpigmentation is a multi-factorial entity.The proposed possible causative factors include genetic or heredity, excessive pigmentation, periorbital edema, thin and translucent lower eyelid skin, venous congestion with hemosiderin deposition, orbital structural problem and shadowing due to skin laxity \& tear trough. Other factors such as underlying systemic, metabolic, hormonal diseases, nutritional deficiencies, drugs, allergic reactions, atopic dermatitis, sleep disorders, stress, alcohol consumption, smoking, frequent cosmetic use, frequent eye rubbing and lack of correction for errors of refraction like myopia are also implicated to POH .
Periorbital hyperpigmentation is classified according to Ranu et al into five categories based on the causative factors 1. Constitutional type: seen as typical brownish curved band on lower eyelid or both. 2.Postinflammatory type: irregular patches of brown or grey pigmentation associated with features of lichenification.3. Vascular type: erythema or prominent capillaries or telangiectasia. 4. Shadow effect type: tear trough and eye bags due to sagging skin around eyes. 5. Others: anaemia, hormonal disturbances, nutritional deficiencies and chronic illnesses .
Periorbital hyperpigmentation is graded into four groups according to the severity of the case to be treated;
- Grade1: characterized by faint pigmentation of infraorbital region.
- Grade 2: pigmentation is more pronounced.
- Grade3: deep dark color, all four lids involved.
- Grade 4: grade 3 + pigmentation spreading beyond infraorbital fold .
The diagnosis of POH is mainly clinically, however, a thorough history and clinical assessment is necessary to identify the contributing etiologic factors. The cutaneous examination should be evaluated to detect the involvement of eyelids, extend beyond the periorbital region, color of hyperpigmentation, presence of any dermatological disease or scar, presence of any visible bulging, skin laxity, tear trough, superficial visible vasculature, in infraorbital region presence of pigmentation in other areas .
Eye lid stretch test or manual stretching of the lower eyelid skin can help to differentiate between true pigmentation and shadowing effect .
Wood's lamp examination is done to differentiate between the epidermal and dermal pigmentation.The variations in epidermal pigmentation become more apparent under Wood's light. For dermal pigmentation, this contrast is less pronounced .
Dermatoscopy: It is a non-invasive diagnostic technique for the in vivo observation of pigmented skin lesion allowing a better visualization of surface and subsurface structures and being easy and feasible to use. It can be used to differentiate the type of POH whenever there is doubt while examining with naked eyes. The dermatoscopic findings of POH are- a) Vascular type: diffuse erythema pattern or multiple thin blood vessels or diffuse vascular network, b) Pigmented type: a pattern of multiple dots with different sizes and colors or a diff use network of pigments and c) Mixed type: Combination of vascular and pigmented type .
Treatment of POH:
There are a number of treatment options available for POH. Among the available treatment options for POH include:
- Topical Applications: The various topical bleaching agents are hydroquinone, kojic acid, a triple combination, azelaic acid, arbutin, topical vitamin C. Out of these topical agents the most widely used is hydroquinone, used in a strength of 2% to 6% .
- Chemical Peelings: Chemical peelings could be used alone or in combination therapy with topical treatments. Glycolic acid 20% is the most commonly used peeling in the treatment of POH. Lactic acid 15% + TCA 3.75% combination is very effective treatment option for POH .
- Lasers: lasers have been used increasingly in cosmetic dermatology. Periorbital hyperpigmentation has been successfully treated with various noninvasive lasers that target pigment and vascularity. Various lasers that have been used for treating dark circles are: Q switched ruby laser (694 nm), Q switched alexanderite laser, and Nd:Yag laser (1064nm).
- Platelet-rich plasma (PRP): PRP is a generic term used to describe a plasma suspension obtained from whole blood, prepared so as to contain platelet concentrations higher than those normally found in circulating blood.
The mechanism of action of PRP is based on the fact that platelets contain many growth factors in their alpha granules. These factors have a well-known role in the process of tissue repair. Thus, the concentration of these substances in injured tissues could be beneficial to providing more agility to the regeneration processes .
PRP treatment is mainly effective for wrinkles, laxity, and secondary PIH-related dark circles. PRP can stimulate dermal fibroblast proliferation and collagen synthesis (Kim DH et al, 2011). Transforming growth factor-β1 and epidermal growth factor in PRP are suggested to inhibit melanin production via delayed extracellular signal-regulated kinase activation and inhibition of prostagandin-E2 expression/ tyrosinase enzyme activity, respectively (Yun WJ et al, 2013). In addition, PRP improves fat graft survival and can be used in combination with autologous fat grafts for dark circles
- Conditions
- Periorbital Hypermelanosis
- Being tested
- PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPOther
platelet rich plasma will be delivered by intradermal method using mestherapy needle.
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
assess cure rate of PRP in treatment of POH
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periorbital HypermelanosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- •The procedure: * The face will be washed thoroughly immediately before the procedure. * Disinfection with alcohol 70% will be done. * A topical anesthetic cream will be applied to the face and left for 30 minutes then it will be removed. * The obtained platelet rich plasma will be delivered by intradermal method using mestherapy needle.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARYousef, Assiut University
- Investigators
- azza rady, doctor, Principal investigator, Assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862118
- Sponsor's protocol ID
- PRP in POH
- Status last verified
- Mar 2019
- First submitted
- 2 Mar 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Badran AY, Abd Elazim NE, Yousef AR, Mekkawy MM. Platelet-Rich Plasma Injections in Periorbital Hyperpigmentation in Skin Phototypes III and IV: Strengthening the Assessment of Treatment Outcomes. Dermatol Surg. 2025 Jan 1;51(1):61-66. doi: 10.1097/DSS.0000000000004372. Epub 2024 Aug 20.
PubMed 39163646
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH)
- ClinicalTrials.gov ID
- NCT03862118
- Acronym / sponsor ID
- PRP in POH
- Conditions
- Periorbital Hypermelanosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 5 Mar 2019 (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.
To evaluate the saftey and efficicacy of autologous PRP in treatment of POH.
Detailed description
Periorbital hyperpigmentation (POH) is a common dermatological condition, also known as periorbital melanosis, periocular hyperpigmentation dark circles under the eyes (DC), infraorbital discoloration, infraorbital darkening, or idiopathic cutaneous hyperchromia of the orbital region. It is a common cosmetic condition that occurs in both sexes and may be considered to be normal variants of pigmentation .
Periorbital hyperpigmentation is a multi-factorial entity.The proposed possible causative factors include genetic or heredity, excessive pigmentation, periorbital edema, thin and translucent lower eyelid skin, venous congestion with hemosiderin deposition, orbital structural problem and shadowing due to skin laxity \& tear trough. Other factors such as underlying systemic, metabolic, hormonal diseases, nutritional deficiencies, drugs, allergic reactions, atopic dermatitis, sleep disorders, stress, alcohol consumption, smoking, frequent cosmetic use, frequent eye rubbing and lack of correction for errors of refraction like myopia are also implicated to POH .
Periorbital hyperpigmentation is classified according to Ranu et al into five categories based on the causative factors 1. Constitutional type: seen as typical brownish curved band on lower eyelid or both. 2.Postinflammatory type: irregular patches of brown or grey pigmentation associated with features of lichenification.3. Vascular type: erythema or prominent capillaries or telangiectasia. 4. Shadow effect type: tear trough and eye bags due to sagging skin around eyes. 5. Others: anaemia, hormonal disturbances, nutritional deficiencies and chronic illnesses .
Periorbital hyperpigmentation is graded into four groups according to the severity of the case to be treated;
- Grade1: characterized by faint pigmentation of infraorbital region.
- Grade 2: pigmentation is more pronounced.
- Grade3: deep dark color, all four lids involved.
- Grade 4: grade 3 + pigmentation spreading beyond infraorbital fold .
The diagnosis of POH is mainly clinically, however, a thorough history and clinical assessment is necessary to identify the contributing etiologic factors. The cutaneous examination should be evaluated to detect the involvement of eyelids, extend beyond the periorbital region, color of hyperpigmentation, presence of any dermatological disease or scar, presence of any visible bulging, skin laxity, tear trough, superficial visible vasculature, in infraorbital region presence of pigmentation in other areas .
Eye lid stretch test or manual stretching of the lower eyelid skin can help to differentiate between true pigmentation and shadowing effect .
Wood's lamp examination is done to differentiate between the epidermal and dermal pigmentation.The variations in epidermal pigmentation become more apparent under Wood's light. For dermal pigmentation, this contrast is less pronounced .
Dermatoscopy: It is a non-invasive diagnostic technique for the in vivo observation of pigmented skin lesion allowing a better visualization of surface and subsurface structures and being easy and feasible to use. It can be used to differentiate the type of POH whenever there is doubt while examining with naked eyes. The dermatoscopic findings of POH are- a) Vascular type: diffuse erythema pattern or multiple thin blood vessels or diffuse vascular network, b) Pigmented type: a pattern of multiple dots with different sizes and colors or a diff use network of pigments and c) Mixed type: Combination of vascular and pigmented type .
Treatment of POH:
There are a number of treatment options available for POH. Among the available treatment options for POH include:
- Topical Applications: The various topical bleaching agents are hydroquinone, kojic acid, a triple combination, azelaic acid, arbutin, topical vitamin C. Out of these topical agents the most widely used is hydroquinone, used in a strength of 2% to 6% .
- Chemical Peelings: Chemical peelings could be used alone or in combination therapy with topical treatments. Glycolic acid 20% is the most commonly used peeling in the treatment of POH. Lactic acid 15% + TCA 3.75% combination is very effective treatment option for POH .
- Lasers: lasers have been used increasingly in cosmetic dermatology. Periorbital hyperpigmentation has been successfully treated with various noninvasive lasers that target pigment and vascularity. Various lasers that have been used for treating dark circles are: Q switched ruby laser (694 nm), Q switched alexanderite laser, and Nd:Yag laser (1064nm).
- Platelet-rich plasma (PRP): PRP is a generic term used to describe a plasma suspension obtained from whole blood, prepared so as to contain platelet concentrations higher than those normally found in circulating blood.
The mechanism of action of PRP is based on the fact that platelets contain many growth factors in their alpha granules. These factors have a well-known role in the process of tissue repair. Thus, the concentration of these substances in injured tissues could be beneficial to providing more agility to the regeneration processes .
PRP treatment is mainly effective for wrinkles, laxity, and secondary PIH-related dark circles. PRP can stimulate dermal fibroblast proliferation and collagen synthesis (Kim DH et al, 2011). Transforming growth factor-β1 and epidermal growth factor in PRP are suggested to inhibit melanin production via delayed extracellular signal-regulated kinase activation and inhibition of prostagandin-E2 expression/ tyrosinase enzyme activity, respectively (Yun WJ et al, 2013). In addition, PRP improves fat graft survival and can be used in combination with autologous fat grafts for dark circles
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- •The procedure: * The face will be washed thoroughly immediately before the procedure. * Disinfection with alcohol 70% will be done. * A topical anesthetic cream will be applied to the face and left for 30 minutes then it will be removed. * The obtained platelet rich plasma will be delivered by intradermal method using mestherapy needle.
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- •Both sexes will be included.
Key exclusion criteria (8 listed)
- • Patients with known platelet dysfunction syndrome, critical thrombocytopenia (<50,000/ul), any hemodynamic instability.
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 |
|---|---|---|
| PRPplatelet rich plasma will be delivered by intradermal method using mestherapy needle. | Other | – |
Primary outcome
cure rate
Time frame: 6 months
assess cure rate of PRP in treatment of POH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Derived from this study: PubMed 39163646Badran AY, Abd Elazim NE, Yousef AR, Mekkawy MM. Platelet-Rich Plasma Injections in Periorbital Hyperpigmentation in Skin Phototypes III and IV: Strengthening the Assessment of Treatment Outcomes. Dermatol Surg. 2025 Jan 1;51(1):61-66. doi: 10.1097/DSS.0000000000004372. Epub 2024 Aug 20.
Related trials for Periorbital Hypermelanosis
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.
azza rady, doctor principal investigator
Assuit university hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRP in people with Periorbital Hypermelanosis, run by Assiut University.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact azza rady, doctor (01275494347, azzaradyyousef2019@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: 6 months). 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 NCT03862118, which also lists 1 linked publication.
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 6 Mar 2019.