Hair TransplantationNCT06849674
Efficacy and Safety of Platelet-Rich Plasma as an Intraoperative Holding Solution in Hair Transplantation
A study testing Platelet rich plasma (PRP) and Saline in people with Hair Transplantation, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hair Transplantation
- What is being tested?
- Platelet rich plasma (PRP) and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2023to 28 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male patients who have androgenetic alopecia
- Patients who are interested in having their hair transplanted
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dermatology, Venereology and Andrology Faculty of Medicine- Benha University
Banhā, Qalyubia Governorate, 13511
About this study
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
- Being tested
- Platelet rich plasma (PRP), Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma (PRP)Biological
Hair grafts will be immersed in autologous Platelwt-richh plasma(PRP) before transplantation.
SalineOther
Hair grafts will be immersed in normal saline solution before transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Saline group | Active comparator | in this group, hair grafts will be stored in Normal saline 0.9% before transplantation. Receives: Other: Saline |
| Platelet-rich plasma group | Experimental | In this group, hair grafts will be stored in Platelet-rich plasma before transplantation. Receives: Biological: Platelet rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%
Measured: 12 weeks after hair transplantation
Secondary outcomes (2)
Patient satisfaction score
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.
Measured: 12weeks after hair translantation
Incidence of Postoperative complications
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
Measured: within 1 month after hair transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start23 May 2023
- Primary completion28 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair TransplantationStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, karem Taha ibrahim khalil, Benha University
- Investigators
- Amany I Mustafa, MD, Study director, Dermatology, Venereology and Andrology Faculty of Medicine- Benha UniversityAhmed I Abdulkhaleq, MBBCh, Study director, Dermatology, Venereology and Andrology Faculty of Medicine- Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849674
- Sponsor's protocol ID
- PRP in hair transplantation
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Platelet-Rich Plasma as an Intraoperative Holding Solution in Hair Transplantation
- ClinicalTrials.gov ID
- NCT06849674
- Acronym / sponsor ID
- PRP in hair transplantation
- Conditions
- Hair Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline group | Active comparator | Other: Salinein this group, hair grafts will be stored in Normal saline 0.9% before transplantation. |
| Platelet-rich plasma group | Experimental | Biological: Platelet rich plasma (PRP)In this group, hair grafts will be stored in Platelet-rich plasma before transplantation. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male patients who have androgenetic alopecia
- Patients who are interested in having their hair transplanted
Key exclusion criteria (8 listed)
- Individuals with comorbidities
- History of keloids or hypertrophic scarring
- Low donor area density
- Other causes of alopecia
- Scalp infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasma (PRP)Hair grafts will be immersed in autologous Platelwt-richh plasma(PRP) before transplantation. | Biological | Platelet-rich plasma group |
| SalineHair grafts will be immersed in normal saline solution before transplantation. | Other | Saline group |
Primary outcome
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.
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%
2 secondary outcomes
Patient satisfaction score
Time frame: 12weeks after hair translantation
Incidence of Postoperative complications
Time frame: within 1 month after hair transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amany I Mustafa, MD study director
Dermatology, Venereology and Andrology Faculty of Medicine- Benha University
Ahmed I Abdulkhaleq, MBBCh study director
Dermatology, Venereology and Andrology Faculty of Medicine- Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma (PRP) and Saline in people with Hair Transplantation, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hair density (time frame: 12 weeks after hair transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.