Efficacy of Platelet-Rich Plasma Versus Mesotherapy in Androgenetic Alopecia: A Retrospective Study

NCT05129800 | Completed

• 1 other identifier: NKS1002
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Androgenetic Alopecia; Hair Loss; Alopecia

Keywords

hair loss; alopecia; platelet-rich plasma; prp; mesotherapy; stem cell conditioned media; recombinant growth factors; phototrichogram; trichoscopy; injector; U225

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  0 months(baseline), 3 months (1 month after treatment), 6 months

Study Arms (4)

PRP 1

This is the group of patients who were injected with 5 ml of PRP prepared using a tube from a company 1

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

Other: Platelet-rich plasma

Mesotherapy 1

This is the group of patients who were injected with mesotherapy from a company 1

Other: Mesotherapy

Mesotherapy 2

This is the group of patients who were injected with mesotherapy from a company 2

Other: Mesotherapy

Interventions

Platelet-rich plasma OTHER

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.

Also known as: PRP 1 / PRP 2, Meaplasma, Regenkit-BCT

PRP 1; PRP 2

Mesotherapy OTHER

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.

Also known as: Mesotherapy 1 / Mesotherapy 2, DermaHeal Stem C rum HL, AllStem Scimed

Mesotherapy 1; Mesotherapy 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Related Publications (1)

• 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.

  PMID: 39386300 RESULT

MeSH Terms

Conditions

Alopecia; Insomnia, Fatal Familial

Interventions

Phosphoglycerate Kinase; Mesotherapy

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Prion Diseases; Central Nervous System Infections; Infections; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Phosphotransferases (Carboxyl Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy

Study Officials

• Athanasios J Stefanis

  Faculty Hospital Kralovske Vinohrady

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: November 22, 2021
• Study Start: January 1, 2011
• Primary Completion: December 30, 2020
• Study Completion: January 30, 2022
• Last Updated: December 3, 2024

Record last verified: 2024-11