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NCT Number: NCT05129800

Efficacy of Platelet-Rich Plasma Versus Mesotherapy 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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Central Nervous System Diseases Central Nervous System Infections Dyssomnias Hair Diseases Hair Loss Hypotrichosis Infections Insomnia, Fatal Familial Nervous System Diseases Neurodegenerative Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prion Diseases Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: PRP 1 / PRP 2, Meaplasma, Regenkit-BCT

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.

Other names: Mesotherapy 1 / Mesotherapy 2, DermaHeal Stem C rum HL, AllStem Scimed

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Faculty Hospital Kralovske Vinohrady

Other Gov

Registry information

Official study title

Efficacy of Platelet-rich Plasma Versus Mesotherapy With Recombinant Growth Factors and Stem Cell Conditioned Media in Androgenetic Alopecia: A Retrospective Study.

Important dates

Study start
2011
Primary completion
2020
Study completion
2022
First posted
Nov 22, 2021
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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