Efficacy and Safety of Platelet-Rich Plasma As an Intraoperative Holding Solution in Hair Transplantation

February 26, 2025 updated by: karem Taha ibrahim khalil, Benha University
The goal of this study is to determine the efficacy of using platelet-rich plasma (PRP) versus 0.9% normal saline as a storage solution during follicular unit extraction (FUE) hair transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubia
      • Benha, Qalyubia, Egypt, 13511
        • Dermatology, Venereology and Andrology Faculty of Medicine- Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male patients who have androgenetic alopecia
  • Patients who are interested in having their hair transplanted

Exclusion Criteria:

  • Individuals with comorbidities
  • History of keloids or hypertrophic scarring
  • Low donor area density
  • Other causes of alopecia
  • Scalp infections
  • Patients with a bleeding tendency
  • Patients on anticoagulant therapy
  • Patients who are HIV-positive or Hepatitis B- or C-positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saline group
in this group, hair grafts will be stored in Normal saline 0.9% before transplantation.
Other: Saline
Hair grafts will be immersed in normal saline solution before transplantation.
Experimental: Platelet-rich plasma group
In this group, hair grafts will be stored in Platelet-rich plasma before transplantation.
Biological: Platelet rich plasma (PRP)
Hair grafts will be immersed in autologous Platelwt-richh plasma(PRP) before transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hair density
Time Frame: 12 weeks after hair transplantation
Hair density (the number of hairs per square centimeter) will be measured using a trichoscope and digital photography in the recipient area.
12 weeks after hair transplantation
Percentage of Hair Growth
Time Frame: 12 weeks after hair transplantation
The percentage of graft survival will be assessed by comparing the number of transplanted hairs to the number of hairs that have grown in the recipient area using trichoscopic analysis and digital photography. The formula used will be: (number of grown hairs/number of transplanted hairs) x100%
12 weeks after hair transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction score
Time Frame: 12weeks after hair translantation
Patient satisfaction will be assessed using Likert scale from 1 to 5 regarding aesthetic results, hair density, and natural appearance. Higher scores indicate greater satisfaction.
12weeks after hair translantation
Incidence of Postoperative complications
Time Frame: within 1 month after hair transplantation
The number and type of complications, including infection,graft necrosis, excessive shedding, and scalp irritation, will be documented. The severity of complications will be assessed using clinical examination and patient reports
within 1 month after hair transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Study Director: Amany I Mustafa, MD, Dermatology, Venereology and Andrology Faculty of Medicine- Benha University
  • Study Director: Ahmed I Abdulkhaleq, MBBCh, Dermatology, Venereology and Andrology Faculty of Medicine- Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Actual)

November 28, 2024

Study Completion (Actual)

November 28, 2024

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • PRP in hair transplantation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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