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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

nagwa easa, professor contact

01280994337

nagwaeasa@yahoo.com

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:

  1. 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% .
  2. 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 .
  3. 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).
  4. 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

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.

  1. 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.

  1. First posted5 Mar 2019
  2. Study start1 Nov 2019 (estimated)
  3. Primary completion1 Nov 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Resources

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)
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

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.

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