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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05129800
• Other study ID #: NKS1002
• Status: Not yet recruiting
• Start date: December 2021
• Est. completion date: February 2022

Study information

• Verified date: November 2021
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: Athanasios J Stefanis, MUDr, MPharm
• Phone: +420775620539
• Email: thstefanis[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia
• Hair Loss

Intervention

Other:
• Platelet-rich plasma
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.
• Mesotherapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady

References & Publications (4)

Gajjar PC, Mehta HH, Barvaliya M, Sonagra B. Comparative Study between Mesotherapy and Topical 5% Minoxidil by Dermoscopic Evaluation for Androgenic Alopecia in Male: A Randomized Controlled Trial. Int J Trichology. 2019 Mar-Apr;11(2):58-67. doi: 10.4103/ijt.ijt_89_18. — View Citation

Kim SJ, Kim MJ, Lee YJ, Lee JC, Kim JH, Kim DH, Do YH, Choi JW, Chung SI, Do BR. Innovative method of alopecia treatment by autologous adipose-derived SVF. Stem Cell Res Ther. 2021 Aug 28;12(1):486. doi: 10.1186/s13287-021-02557-6. — View Citation

Melo DF, de Mattos Barreto T, Plata GT, Araujo LR, Tortelly VD. Excellent response to mesotherapy as adjunctive treatment in male androgenetic alopecia. J Cosmet Dermatol. 2020 Jan;19(1):75-77. doi: 10.1111/jocd.12983. Epub 2019 May 8. — View Citation

Tak YJ, Lee SY, Cho AR, Kim YS. A randomized, double-blind, vehicle-controlled clinical study of hair regeneration using adipose-derived stem cell constituent extract in androgenetic alopecia. Stem Cells Transl Med. 2020 Aug;9(8):839-849. doi: 10.1002/sctm.19-0410. Epub 2020 May 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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