A Comparative Study of Microneedling with Platelet-rich Plasma Plus Topical Minoxidil (5%) and Topical Minoxidil (5%) Alone in Androgenetic Alopecia.

CONTEXT: There are very few studies evaluating efficacy of platelet-rich plasma (PRP) in hair restoration and its combination with microneedling. As far as ascertained, there is no study to evaluate efficacy of microneedling with PRP plus topical minoxidil (5%) versus topical minoxidil (5%) alone in androgenetic alopecia (AGA). AIMS: This study aims (1) to compare the efficacy of (a) topical minoxidil (5%) alone and (b) topical minoxidil (5%) + microneedling with PRP in men between 18 and 50 years with AGA Grade III to V vertex (Norwood-Hamilton scale) and (2) to perform objective and subjective evaluation based on clinical improvement and photographic evidence. SETTINGS AND
DESIGN: The study was conducted in the outpatient department of dermatology, venereology, and leprology in tertiary care hospital. It was open, prospective study. SUBJECTS AND METHODS: Fifty patients with AGA were selected on the basis of inclusion and exclusion criteria. These patients were randomly divided into two groups of 25 patients each and were given following treatment: (i) Group A: topical minoxidil (5%) alone and (ii) Group B: topical minoxidil (5%) + microneedling with platelet-rich plasma (PRP). STATISTICAL ANALYSIS USED: Patients were assessed before starting the treatment and at the end of 6 months on the basis of (a) Patient's self-assessment based on standardized seven-point scale compared with baseline (b) Physician's assessment based on standardized seven-point scale of hair growth compared with baseline.
RESULTS: There was a significant improvement (P < 0.05) in both patients' assessment and investigator's assessment in Group B as compared to Group A at the end of 6 months.
CONCLUSIONS: Microneedling with PRP is safe, effective, and a promising tool for the management of AGA.

RCT Entities:   Population Interventions Outcomes

INTRODUCTION

Androgenetic alopecia (AGA) or common baldness is the result of progressive, patterned hair loss that occurs when genetically predisposed individuals are exposed to androgens.[1]

AGA occurs by androgen-mediated conversion of terminal hairs to vellus hairs.[2] By far, the most promising approaches to the treatment of AGA are drug therapies, such as minoxidil and finasteride.[3] These may not be always effective, take long time to show results and may be sometimes associated with unacceptable side effect of sexual dysfunction. Hence, there is a need for adjuvant and newer modalities of treatment to look forward for therapy which gives faster and better results. Microneedling using dermaroller creates multiple microchannels and increases transdermal penetration of drugs, facilitating higher concentration in dermis.[45]

There are very few studies evaluating the efficacy of platelet-rich plasma (PRP) in hair restoration and its combination with dermaroller. As far as ascertained, there is no study to evaluate efficacy of microneedling with PRP plus topical minoxidil (5%) versus topical minoxidil (5%) alone in AGA.

Aims and objectives of this study were

To analyze and compare the efficacy of topical minoxidil (5%) alone and topical minoxidil (5%) + microneedling with PRP.

In men, between 18 and 50 years with AGA Grade III to V vertex (Norwood–Hamilton scale).

To perform objective and subjective evaluation based on clinical improvement, photographic evidence

To observe untoward events or side effects, if any.

SUBJECTS AND METHODS

Fifty patients with AGA were selected on the basis of inclusion and exclusion criteria. These patients were randomly divided into two groups of 25 patients each.

Group A: topical minoxidil (5%) alone

Group B: topical minoxidil (5%) + microneedling with PRP.

Inclusion criteria

Patients willing for the procedure

Patients in the age group of 18–50 years

Patients with AGA Stage III–V Hamilton–Norwood classification

Patients who have not taken any form of treatment, at least in the past 6 months.

Exclusion criteria

Patients with alopecia other than AGA, such as alopecia areata, alopecia totalis, telogen effluvium, anagen effluvium, and acquired cicatricial alopecia.

Patients with history of bleeding disorders

Patients on anticoagulant medications (aspirin, warfarin, heparin)

Patients with active infection at the local site

Patients with keloidal tendency

Patients with history of psoriasis or lichen planus because of risk of Koebner phenomenon

Hepatic, renal disease, epilepsy, or any major medical illness

Patients with unrealistic expectations

Patients not giving consent

Patients who could come for regular follow-up were selected and included in the study. After taking the written and informed consent, patients were enrolled in the study and procedure was started

For Group A:

Patients were instructed to apply topical 5% minoxidil in a dose of 1ml twice daily during the treatment period.

For Group B:

Patients were instructed to apply topical 5% minoxidil in a dose of 1ml twice daily during the treatment period. They also received treatment in the form of microneedling with PRP once at the interval of a month for 6 sittings.

Microneedling with PRP:

Scalp was prepared with betadine and normal saline following topical anesthesia. Rolling was done with dermaroller with needle length 1.5 mm over affected areas in longitudinal, vertical, and diagonal directions, 8 times in each direction or until mild erythema was noted which was considered as the end point. This activation of scalp with microneedling was followed by PRP injections 0.05 ml per 1cm square in a retrograde fashion from deep to superficial at every centimeter over the treatment area, and then, application of extracted plasma on the activated site and massaging was done to allow it to percolate through the epidermis and left overnight

A total of 6 such sittings were given to each patient at an interval of 1 month, over a total period of 6 months after which topical therapy with minoxidil was continued. Patients were instructed not to alter their hair style or dye their hair during the study period

Patients were assessed before starting the treatment and at the end of 6 months on the basis of:

Patient's self assessment based on standardized seven point scale compared with baseline which is shown in Table 1.

Table 1

Patient’s assessment of improvement on 7-point scale

Physician's assessment based on standardized seven point scale of hair growth compared with baseline which is shown in Table 2.

Table 2

Physician's assessment of improvement on 7-point scale

Patient's self-assessment

The patients' perception of improvement in the degree of hair fall and hair growth was evaluated from the baseline on a seven-point scale

Physician's assessment

Physician assessed the standardized color photographs taken at baseline and at the end of 3 months and 6 months. The photographs were taken with fixed position, angle, light, magnification, and distance (8 cm) using SONY DSC TX-55. The photographed area included vertex, midline frontal, and temporal regions. These photographs were assessed on a standard seven-point scale at the end of 6 months, and following scores were noted:

Hamilton–Norwood scale for male pattern hair loss was used, and subsequent improvement in the grading was noted.

RESULTS

About 40% (n = 10) patients in Group A and 44% (n = 11) patients in Group B were in age group 21–30 years whereas 28% (n = 7) patients in Group A and 32% (n = 8) patients in Group B were in age group 31–40 years. Average age in Group A and B were 30.04 and 31.12 years, respectively, which were comparable, and difference was not statistically significant (P > 0.05) (Chi-square test). Nearly, 62% (n = 31) patients had hair loss duration of 1–5 years. Maximum duration of hair loss was of 15 years, for three patients seeking advice. There was not much difference in duration of hair loss of the patients in both the groups. In the study of total fifty male patients, 25 (50%) patients had Grade III alopecia, and 16 (32%) patients had Grade IV alopecia. Maximum patients were of Grade III alopecia. Family history was positive in 54% (n = 27) patients in our study. As shown in Table 3, there is a significant improvement (P < 0.05) in patients' assessment in Group B as compared to Group A at the end of 6 months. As shown in Table 4, there is a significant improvement (P < 0.05) in investigator's assessment in Group B as compared to Group A at the end of 6 months. As shown in Table 5, there is a significant improvement (P < 0.05 using paired sample t-test) in platelet count in PRP compared to whole blood. The results of group A are shown in Figures 1–4 and the results of group B are shown in Figures 5–8 which shows that there is significant improvement in group B patients when compared to group A patients.

Table 3

Comparison of patients' assessment at the end of 6 months between two Groups A and B using Chi-square test

Table 4

Comparison of investigator assessment at the end of 6 months between two Groups A and B using Chi-square test

Table 5

Comparison of platelet count in whole blood and platelet-rich plasma in Group B

Figure 1

Patient 1: At the beginning of treatment (Group A)

Figure 4

Patient 2: After 6 months of treatment (Group A)

Figure 5

Patient 3: At the beginning of treatment (Group B)

Figure 8

Patient 4: After 6 months of treatment (Group B)

Patient 1: After 6 months of treatment (Group A)

Patient 2: At the beginning of treatment (Group A)

Patient 3: After 6 months of treatment (Group B)

Patient 4: At the beginning of treatment (Group B)

DISCUSSION

In a study done by De Villez,[6] average age of patients with male pattern baldness was 36.9 years; while in a study done by Hajheydari et al.,[7] it was 22.8 years. In our study, average age of patients with male pattern baldness was 30.6 years. In a study done by Hajheydari et al.,[7] average time of hair loss was 23.10 months, while in our study, it was 54.54 months. In a study done by Krupa Shankar et al.,[8] 27.27% patients had Grade II alopecia, 22.12% patients had Grade I alopecia, 21.78% patients had Grade III alopecia, 10.8% patients had Grade IV alopecia, and 6% patients had Grade V alopecia. In our study, 50% patients had Grade III alopecia, 32%patients had Grade IV alopecia, and 18% patients had Grade V alopecia. Family history was found positive in 54% (n = 27) patients in our study which was more as compared to 48.5% positivity in Paik et al.,[9] study and less compared to 81.6% positivity in a study done by Hajheydari et al.,[7] Betsi et al.,[10] study finds that global pictures showed a significant improvement in hair volume and quality, which was confirmed by a high overall patient satisfaction in patients treated with PRP for hair loss. Dhurat et al.[11] study finds that dermaroller along with minoxidil-treated group was statistically superior to minoxidil-treated Group in promoting hair growth in men. We could not find any studies comparing the efficacy of minoxidil plus microneedling with PRP to minoxidil alone. Greco and Brandt,[12] Kang et al.,[13] Park et al.,[14] and Lopez et al.[15] have shown that interfollicular injections of PRP (mesotherapy) produce significant increase in hair shaft diameter, growth rate, and hair density. Greco and Brandt[12] found that traumatizing scalp and infusing PRP into the scalp reversed miniaturization over an 8-month period when compared with control and significant increase of 9.7% in average hair shaft diameter at 4 months and then 6.1% at 8 months in the treatment group was noted. The exact platelet concentration (in PRP) required to achieve hair regrowth is not known. It may seem that higher platelet concentrations are desirable but as suggested by Anitua et al.,[16] the “more is better” approach is not always the case. Supporting this opinion are the reports that high concentrations of growth factors transforming growth factor-beta, epidermal growth factor, and platelet-derived growth factor may contribute to impaired wound healing and increased scarring.[17]

The method used for PRP preparation in our study yields around three times the baseline platelet count. Significant increase in hair density was seen at the end of 6 months after treatment with PRP containing average three times of baseline platelet count. Further studies comparing efficacy of PRP in hair regrowth at different concentrations are required to know the exact concentration of platelet required to achieve optimum hair regrowth. Most common side effect in our study was pruritus in eight patients followed by seborrheic dermatitis seen in 7 patients and headache in six patients. In Tsuboi et al.[18] study, headache was seen in 3%, pruritus seen in 1%, and dermatitis seen in 2%.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.