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Status unknownNCT03862118Updated Mar 6, 2019

Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH)

A Phase 3 interventional study of PRP in Periorbital Hypermelanosis, sponsored by Assiut University. Status unknown. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-03-06.

Sponsored by Assiut University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Periorbital Hypermelanosis

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03

In context

Hyperpigmentation

102 studies on the registry are indexed under Hyperpigmentation; 20 are open to participants now.

This study's planned enrollment of 30 is below the median of 38 across 89 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • •Both sexes will be included.

    • Age (20-50)
    • Patient with Fitzpatrick skin types III-IV

Exclusion criteria

Exclusion Criteria:

    • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • OtherPRP

    platelet rich plasma will be delivered by intradermal method using mestherapy needle.

06

What researchers measure

Primary outcomes

  1. cure rate

    assess cure rate of PRP in treatment of POH

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03862118
Lead sponsor
Assiut University
Responsible party
ARYousef (principal investigator, Assiut University) — Principal investigator
First posted
Mar 5, 2019
Start date
Nov 1, 2019 (estimated)
Primary completion
Nov 1, 2020 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Mar 6, 2019

Study contacts

azza rady, doctor
Contact
azzaradyyousef2019@yahoo.com
01275494347
nagwa easa, professor
Contact
nagwaeasa@yahoo.com
01280994337
azza rady, doctor
principal investigator · Assuit university hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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