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

NCT06849674 | Completed DMC

• 1 other identifier: PRP in hair transplantation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hair Transplantation

Outcome Measures

Primary Outcomes (2)

• Change in Hair density

  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

  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 Outcomes (2)

• Patient satisfaction score

  12weeks after hair translantation

• Incidence of Postoperative complications

  within 1 month after hair transplantation

Study Arms (2)

Saline group

ACTIVE COMPARATOR

in this group, hair grafts will be stored in Normal saline 0.9% before transplantation.

Other: Saline

Platelet-rich plasma group

EXPERIMENTAL

In this group, hair grafts will be stored in Platelet-rich plasma before transplantation.

Biological: Platelet rich plasma (PRP)

Interventions

Platelet rich plasma (PRP) BIOLOGICAL

Hair grafts will be immersed in autologous Platelwt-richh plasma(PRP) before transplantation.

Platelet-rich plasma group

Saline OTHER

Hair grafts will be immersed in normal saline solution before transplantation.

Saline group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Dermatology, Venereology and Andrology Faculty of Medicine- Benha University

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology,Venereology and Anddrology

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 27, 2025
• Study Start: May 23, 2023
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

EG (1)