Androgenetic AlopeciaNCT05129800
Efficacy of Platelet-Rich Plasma Versus Mesotherapy in Androgenetic Alopecia: A Retrospective Study
An observational study of Androgenetic Alopecia and Hair Loss, run by Faculty Hospital Kralovske Vinohrady.
Trial summary
This is a comparative retrospective study of the efficacy of platelet-rich plasma injections and injections with commercial products advertised to promote hair regrowth for patients with androgenetic alopecia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Androgenetic Alopecia, Hair Loss, Alopecia
- What is being tested?
- Platelet-rich plasma and Mesotherapy
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 30 Jan 2022
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with androgenetic alopecia who visited the outpatients department of our dermatology clinic of our university hospital. Patients were mostly Czech citizens but also expats who worked and lived in the country at the time of visit.
Who may be able to join
- Patients who underwent either PRP or mesotherapy at our dermatology clinic during 1/1/2011 and 30/12/2020
- Male patients with a clinical/ trichoscopic/ histologic diagnosis of androgenetic alopecia (stage II to V according to the Hamilton-Norwood Scale)
- Female patients with a clinical/ trichoscopic/ histologic diagnosis of androgenetic alopecia (stage I to III according to Ludwig Classification)
- Patients receiving no treatment or being treated for more than six months for androgenetic alopecia without change in medication. Examples of medications and interventions include, oral/topical finasteride, oral/topical minoxidil, antiandrogens, hormonal substitution, hormonal contraceptives, phototherapy/laser, cryotherapy, microneedling.
- Patients who underwent trichoscopic examination and phototrichographic evaluation with our digital dermatoscope, before treatment, a month after the last injection and 3 months after treatment.
- Trichoscopic photos are required to be taken from the midfrontal area and from the vertex -defined as the intersection of the line through the midsagittal line and the line passing through the external auditory canals in the coronal plane.
Who cannot join
- Patients with other types of alopecia, other than androgenetic alopecia
- Patients with two or more diagnoses of hair loss , for example androgenetic alopecia and telogen effluvium or alopecia areata.
- Patients who started concomitant medication for hair loss within six months of treatment with PRP or mesotherapy. Medications and interventions include, oral/topical finasteride, oral/topical minoxidil, antiandrogens, hormonal substitution, hormonal contraceptives, phototherapy/laser, cryotherapy, microneedling.
- Hair transplantation to the vertex /midfrontal area
- Patients with no trichoscopic examination/ phototrichographic evaluation
- Patients lost to follow-up / withdrew from treatment
About this study
Official title: Efficacy of Platelet-rich Plasma Versus Mesotherapy With Recombinant Growth Factors and Stem Cell Conditioned Media in Androgenetic Alopecia: A Retrospective Study.
This is a comparative retrospective study of the efficacy of platelet-rich plasma injections and injections with commercial products advertised to promote hair regrowth for patients with androgenetic alopecia.
Read the detailed description
Platelet-rich plasma (PRP) has been used for more than a decade in the treatment of androgenetic alopecia and hair loss. Platelets contain a range of growth factors , namely vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), epidermal growth factor (EGF) and transforming growth factor beta (TGF-beta) which stimulate and support hair growth. Several studies have been performed on patients with conflicting but generally positive results.
Mesotherapy is the technique of injecting a product into the dermis and subcutaneous tissue in order to rejuvenate the skin, induce lipolysis or promote hair growth. Various products exist with different formulations marketed to induce hair growth and sustain hair loss. Even though these products have been used for years, clinical evidence is lacking.
In this retrospective study, we will compare the efficacy of PRP and mesotherapy on hair growth based on the trichoscopic photos and phototrichographic analyses of our patients who underwent these procedures between 2011 and 2020.
- Conditions
- Androgenetic Alopecia, Hair Loss, Alopecia
- Being tested
- Platelet-rich plasma, Mesotherapy
- Keywords
- hair loss, alopecia, platelet-rich plasma, prp, mesotherapy, stem cell conditioned media, recombinant growth factors, phototrichogram, trichoscopy, injector, U225
- Medical subject headings
- Alopecia, Insomnia, Fatal Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaOther
Also called PRP 1 / PRP 2, Meaplasma, Regenkit-BCT
PRP preparation involved, withdrawal 8-10ml from each patient into a tube containg either 3,8 % sodium citrate and either enoxaparin gel or thixotropic cell-separation gel. The tubes were centrifuged at either 3900 rpm for 10 minutes or at 1500g for 5 minutes, resulting in four layers: a cell-rich layer at the bottom of the tube covered by the separating gel, a PRP layer on top of the gel, and a platelet-poor plasma (PPP) layer at the top. The tube was gently agitated in order to mix the PPP with the PRP. The solution, cca 4-5ml, was withdrawn with a needle and injected to the scalp-frontoparietal region using either a syringe and a 4mm needle or an injector. According to the protocol of our hospital, the injections to the scalp were spaced 0.5-1cm apart.
PRP was applied once every month for 3 months. Macroscopic and digital phototrichographic photos were taken before the beginning of treatment, 1 month after the last injection, and 3 months after the end of treatmert.
MesotherapyOther
Also called Mesotherapy 1 / Mesotherapy 2, DermaHeal Stem C rum HL, AllStem Scimed
For mesotherapy, usually around 5ml of saline solution was withdrawn using a needle and released to the selected ampule containing adipose tissue stem-cell conditioned media and mixture of recombinant growth factors, in a powder form. We used preparations from two different companies, differing in the combination and concentration of ingredients. After the injection of normal saline, the ampule was gently agitated in order to disperse the powder and injected to the scalp-frontoparietal region using either a syringe and a 4mm needle or a gun injector. The injections were spaced 0.5-1cm apart.
Mesotherapy was repeated every 1-2 weeks for 6-7 times according to the protocol recommended for each preparation. Macroscopic and phototrichographic photos were taken before the beginning of treatment, a month after the last injection and 3 months after the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| PRP 1 | This is the group of patients who were injected with 5 ml of PRP prepared using a tube from a company 1 Receives: Other: Platelet-rich plasma | |
| PRP 2 | This is the group of patients who were injected with 5 ml of PRP prepared using a tube from a company 2 Receives: Other: Platelet-rich plasma | |
| Mesotherapy 1 | This is the group of patients who were injected with mesotherapy from a company 1 Receives: Other: Mesotherapy | |
| Mesotherapy 2 | This is the group of patients who were injected with mesotherapy from a company 2 Receives: Other: Mesotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hair thickness at 3 months at at 6 months from baseline
Difference (%) in hair diameter in μm as measured by the phototrichographic software with photos taken from the frontal area and from the vertex
Measured: 0 months(baseline), 3 months (1 mont after treatment), 6 months
Change in hair density at 3 months and at 6 months from baseline
Difference (%) in the number of hair /cm2 as measured by the phototrichographic software with photos taken from the frontal area and from the vertex.
Measured: 0 months(baseline), 3 months (1 month after treatment), 6 months
Change in hair count at 3 months and at 6 months from baseline
Difference (%) in the total number of hair as measured by the phototrichographic software with photos taken from the frontal area and from the vertex.
Measured: 0 months(baseline), 3 months (1 month after treatment), 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Jan 2011
- Primary completion30 Dec 2020
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Athanasios J. Stefanis, Faculty Hospital Kralovske Vinohrady
- Investigators
- Athanasios J Stefanis, Principal investigator, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129800
- Sponsor's protocol ID
- NKS1002
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2021
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stefanis AJ, Arenberger P, Arenbergerova M, Rigopoulos D. Efficacy of Platelet-Rich Plasma versus Mesotherapy with Recombinant Growth Factors and Stem Cell-Conditioned Media in Androgenetic Alopecia: A Retrospective Study. Skin Appendage Disord. 2024 Oct;10(5):376-382. doi: 10.1159/000539105. Epub 2024 Jun 5.
PubMed 39386300
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-rich Plasma Versus Mesotherapy With Recombinant Growth Factors and Stem Cell Conditioned Media in Androgenetic Alopecia: A Retrospective Study.
- ClinicalTrials.gov ID
- NCT05129800
- Acronym / sponsor ID
- NKS1002
- Conditions
- Androgenetic Alopecia, Hair Loss, Alopecia
- Keywords
- hair loss, alopecia, platelet-rich plasma, prp, mesotherapy, stem cell conditioned media, recombinant growth factors, phototrichogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 22 Nov 2021 (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.
This is a comparative retrospective study of the efficacy of platelet-rich plasma injections and injections with commercial products advertised to promote hair regrowth for patients with androgenetic alopecia.
Detailed description
Platelet-rich plasma (PRP) has been used for more than a decade in the treatment of androgenetic alopecia and hair loss. Platelets contain a range of growth factors , namely vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), epidermal growth factor (EGF) and transforming growth factor beta (TGF-beta) which stimulate and support hair growth. Several studies have been performed on patients with conflicting but generally positive results.
Mesotherapy is the technique of injecting a product into the dermis and subcutaneous tissue in order to rejuvenate the skin, induce lipolysis or promote hair growth. Various products exist with different formulations marketed to induce hair growth and sustain hair loss. Even though these products have been used for years, clinical evidence is lacking.
In this retrospective study, we will compare the efficacy of PRP and mesotherapy on hair growth based on the trichoscopic photos and phototrichographic analyses of our patients who underwent these procedures between 2011 and 2020.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRP 1 | – | Other: Platelet-rich plasmaThis is the group of patients who were injected with 5 ml of PRP prepared using a tube from a company 1 |
| PRP 2 | – | Other: Platelet-rich plasmaThis is the group of patients who were injected with 5 ml of PRP prepared using a tube from a company 2 |
| Mesotherapy 1 | – | Other: MesotherapyThis is the group of patients who were injected with mesotherapy from a company 1 |
| Mesotherapy 2 | – | Other: MesotherapyThis is the group of patients who were injected with mesotherapy from a company 2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with androgenetic alopecia who visited the outpatients department of our dermatology clinic of our university hospital. Patients were mostly Czech citizens but also expats who worked and lived in the country at the time of visit.
Key inclusion criteria (6 listed)
- Patients who underwent either PRP or mesotherapy at our dermatology clinic during 1/1/2011 and 30/12/2020
- Male patients with a clinical/ trichoscopic/ histologic diagnosis of androgenetic alopecia (stage II to V according to the Hamilton-Norwood Scale)
- Female patients with a clinical/ trichoscopic/ histologic diagnosis of androgenetic alopecia (stage I to III according to Ludwig Classification)
- Patients receiving no treatment or being treated for more than six months for androgenetic alopecia without change in medication. Examples of medications and interventions include, oral/topical finasteride, oral/topical minoxidil, antiandrogens, hormonal substitution, hormonal contraceptives, phototherapy/laser, cryotherapy, microneedling.
- Patients who underwent trichoscopic examination and phototrichographic evaluation with our digital dermatoscope, before treatment, a month after the last injection and 3 months after treatment.
Key exclusion criteria (6 listed)
- Patients with other types of alopecia, other than androgenetic alopecia
- Patients with two or more diagnoses of hair loss , for example androgenetic alopecia and telogen effluvium or alopecia areata.
- Patients who started concomitant medication for hair loss within six months of treatment with PRP or mesotherapy. Medications and interventions include, oral/topical finasteride, oral/topical minoxidil, antiandrogens, hormonal substitution, hormonal contraceptives, phototherapy/laser, cryotherapy, microneedling.
- Hair transplantation to the vertex /midfrontal area
- Patients with no trichoscopic examination/ phototrichographic evaluation
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 plasmaAlso: PRP 1 / PRP 2, Meaplasma, Regenkit-BCTPRP preparation involved, withdrawal 8-10ml from each patient into a tube containg either 3,8 % sodium citrate and either enoxaparin gel or thixotropic cell-separation gel. The tubes were centrifuged at either 3900 rpm for 10 minutes or at 1500g for 5 minutes, resulting in four layers: a cell-rich layer at the bottom of the tube covered by the separating gel, a PRP layer on top of the gel, and a platelet-poor plasma (PPP) layer at the top. The tube was gently agitated in order to mix the PPP with the PRP. The solution, cca 4-5ml, was withdrawn with a needle and injected to the scalp-frontoparietal region using either a syringe and a 4mm needle or an injector. According to the protocol of our hospital, the injections to the scalp were spaced 0.5-1cm apart. PRP was applied once every month for 3 months. Macroscopic and digital phototrichographic photos were taken before the beginning of treatment, 1 month after the last injection, and 3 months after the end of treatmert. | Other | PRP 1, PRP 2 |
| MesotherapyAlso: Mesotherapy 1 / Mesotherapy 2, DermaHeal Stem C rum HL, AllStem ScimedFor mesotherapy, usually around 5ml of saline solution was withdrawn using a needle and released to the selected ampule containing adipose tissue stem-cell conditioned media and mixture of recombinant growth factors, in a powder form. We used preparations from two different companies, differing in the combination and concentration of ingredients. After the injection of normal saline, the ampule was gently agitated in order to disperse the powder and injected to the scalp-frontoparietal region using either a syringe and a 4mm needle or a gun injector. The injections were spaced 0.5-1cm apart. Mesotherapy was repeated every 1-2 weeks for 6-7 times according to the protocol recommended for each preparation. Macroscopic and phototrichographic photos were taken before the beginning of treatment, a month after the last injection and 3 months after the end of treatment. | Other | Mesotherapy 1, Mesotherapy 2 |
Primary outcome
Change in hair thickness at 3 months at at 6 months from baseline
Time frame: 0 months(baseline), 3 months (1 mont after treatment), 6 months
Difference (%) in hair diameter in μm as measured by the phototrichographic software with photos taken from the frontal area and from the vertex
Change in hair density at 3 months and at 6 months from baseline
Time frame: 0 months(baseline), 3 months (1 month after treatment), 6 months
Difference (%) in the number of hair /cm2 as measured by the phototrichographic software with photos taken from the frontal area and from the vertex.
Change in hair count at 3 months and at 6 months from baseline
Time frame: 0 months(baseline), 3 months (1 month after treatment), 6 months
Difference (%) in the total number of hair as measured by the phototrichographic software with photos taken from the frontal area and from the vertex.
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 3 Dec 2024.
- Results publication: PubMed 39386300Stefanis AJ, Arenberger P, Arenbergerova M, Rigopoulos D. Efficacy of Platelet-Rich Plasma versus Mesotherapy with Recombinant Growth Factors and Stem Cell-Conditioned Media in Androgenetic Alopecia: A Retrospective Study. Skin Appendage Disord. 2024 Oct;10(5):376-382. doi: 10.1159/000539105. Epub 2024 Jun 5.
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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.
Athanasios J Stefanis principal investigator
Faculty Hospital Kralovske Vinohrady
Questions about this trial
What is this clinical trial studying?
An observational study of Androgenetic Alopecia and Hair Loss, run by Faculty Hospital Kralovske Vinohrady.
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 6 inclusion and 6 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 thickness at 3 months at at 6 months from baseline (time frame: 0 months(baseline), 3 months (1 mont after treatment), 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129800, which also lists 1 linked publication.
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 3 Dec 2024.