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

Primary Purpose

Periorbital Hypermelanosis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PRP
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periorbital Hypermelanosis

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • •Both sexes will be included.

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

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    cure rate
    assess cure rate of PRP in treatment of POH

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2019
    Last Updated
    March 5, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03862118
    Brief Title
    Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH)
    Official Title
    Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periorbital Hypermelanosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    PRP
    Intervention Description
    platelet rich plasma will be delivered by intradermal method using mestherapy needle.
    Primary Outcome Measure Information:
    Title
    cure rate
    Description
    assess cure rate of PRP in treatment of POH
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: •Both sexes will be included. Age (20-50) Patient with Fitzpatrick skin types III-IV 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    azza rady, doctor
    Phone
    01275494347
    Email
    azzaradyyousef2019@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    nagwa easa, professor
    Phone
    01280994337
    Email
    nagwaeasa@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    azza rady, doctor
    Organizational Affiliation
    Assuit university hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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