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

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ClinicalTrials.gov Identifier: NCT03862118
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
ARYousef, Assiut University

Brief Summary:
To evaluate the saftey and efficicacy of autologous PRP in treatment of POH.

Condition or disease Intervention/treatment Phase
Periorbital Hypermelanosis Other: PRP Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH)
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Intervention Details:
  • Other: PRP
    platelet rich plasma will be delivered by intradermal method using mestherapy needle.


Primary Outcome Measures :
  1. cure rate [ Time Frame: 6 months ]
    assess cure rate of PRP in treatment of POH



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862118


Contacts
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Contact: azza rady, doctor 01275494347 azzaradyyousef2019@yahoo.com
Contact: nagwa easa, professor 01280994337 nagwaeasa@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: azza rady, doctor Assuit university hospital

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Responsible Party: ARYousef, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03862118     History of Changes
Other Study ID Numbers: PRP in POH
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases