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

NCT03862118 | Unknown Phase 3

• 1 other identifier: PRP in POH
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Periorbital Hypermelanosis

Outcome Measures

Primary Outcomes (1)

• cure rate

  assess cure rate of PRP in treatment of POH

  6 months

Interventions

PRP OTHER

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

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both sexes will be included.
• Age (20-50)
• Patient with Fitzpatrick skin types III-IV

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 39163646 DERIVED

Study Officials

• azza rady, doctor

  Assuit university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

azza rady, doctor

CONTACT

01275494347; azzaradyyousef2019@yahoo.com

nagwa easa, professor

CONTACT

01280994337; nagwaeasa@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: •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.

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 5, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 6, 2019

Record last verified: 2019-03