New Study Fails to Show Benefits of Microneedling in Males with Balding.

Small Study Finds No Benefit to Scalp Microneedling in Males with Balding.

Microneedling is a recently described technique that consists of multiple punctures deep enough to reach the superficial dermis and trigger an inflammatory stimulus with consequent neocollagenesis and release of growth factors

Many prior studies have evaluated the benefits of microneedling in association with other treatments. One such study is the well known Dhurat et al 2013 study

DHURAT ET AL 2013.

This 2013 study of 100 patients supported the benefit of dermarolling. The study set out to determine if patients who use topical minoxidil (Rogaine, etc) could achieve even further benefit by dermarolling. In the study, half the patients received daily minoxidil and the other half of the patients received weekly dermarolling sessions (using a 1.5 mm dermaroller) in addition to minoxidil treatment. Results showed that patients using a dermaroller achieved greater benefits than those using minoxidil alone. Specifically, 82 % of patients receiving dermarolling felt they achieved greater than a 50 % benefit in their hair compared to just 4.5 % receiving minoxidil alone. Physicians rated the improvements similarly. Hair counts (at an up close level) were increased in the dermarolling group compared to the minoxidil alone group (91.4 vs 22.2 respectively).

Kakizaki et al., 2023

 The aim of this new study was to evaluate the benefits as well as the risks of isolated scalp microneedling in patients with male pattern hair loss.  

30 male patients were enrolled in the study and were randomized to two different microneedling device groups: roller (n = 15) and tattoo cartridge (n = 15). All patients then had scalp microneedling treatments every 4 weeks for a total of 4 times. Follow-up visits occurred 4 and 16 weeks after the last session with a total study duration of 32 weeks.

Microneedling Devices Studied

The authors studied two commercially available microneedling devices - both set at a depth of 1.5 mm. These were the 1) Dr Roller rollers with 192 needles and 2) Cheyenne tattoo machine with magnum Art.-Nr. E-MC27-M30L cartridges containing 17 needles. Microneedling was done until pinpoint bleeding. Both devices were applied with the same technique. Participants were instructed not to wash the area for 24 hours.

How were outcomes assessed?

1) Scalp coverage changes observed in clinical pictures taken before and after treatment were graded by three blinded evaluators using a standardized 7-point rating scale (−3 = greatly decreased, −2 = moderately decreased, −1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased).

2) Hair density was analyzed through dermoscopy pictures taken from a 0.79-square inch clipped area. Central tattooing was done to help ensure reproducibility of the same area at different times. The image was analyzed by an automated validated hair counting method (Trichoscan).

3) Biopsies were also taken to assess for the presence of new collagen bundles and destruction of elastic fibers. Neocollagenesis and elastolysis secondary to scalp microneedling were analyzed in 4-mm punch biopsies of the scalp.

RESULTS

A total of 30 patients were included in the study, 15 in the roller group and 15 in the tattoo cartridge group. Three participants in the roller group and one participant in the tattoo cartridge group did not present for the first follow-up visit. For the second follow-up visit (16 weeks after the last microneedling session), there were another 4 patients in the roller group and another 3 patients in the tattoo cartridge group who were lost of follow-up. That means there were just 12 patients  in the roller group and 14 patients in the cartridge group for assessment at visit 1 (i.e. at week 4). There were just 8 patients final in the roller group and 9 patients in the cartridge group for assessment (i.e. at week 16).  

The mean age of the population was 45.6 years and ranged from 23–67 years. Duration of baldness varied from 2 to 30 years, with a mean of 12.8 years. The mean age at onset of the disease was 31.6 ± 11.3 years. The stage of MPHL did not differ among groups and patients were in baldness stages IIIv, IV, V, VI

At the first follow-up visit, 4/12 participants in the roller group and 2/14 participants in the tattoo cartridge group showed an improvement in clinical pictures. Among the responders, only 2 patients in the roller group and one in the cartridge group sustained an improvement on the last follow-up visit.

Neither group presented an improvement in total hair count after 4 monthly sessions of scalp microneedling. In fact there was a trend towards decreased density.

In terms of side effects, there were no reports of local infection, erythema, edema, seborrheic dermatitis, and itching during the study protocol.

The presence of neocollagenesis and elastolysis was noted in scalp biopsies of 6 and 4 patients, respectively.

CONCLUSION

This was a nicely done, albeit small, study that evaluated the effectiveness of two commercially available microneedling devices. The study showed no benefit in hair density or scalp coverage for MPHL patients after 4 monthly sessions of scalp microneedling. The authors point out that there results differ from previous studies that showed improvement in hair growth parameters in MPHL patients after scalp microneedling.

 It’s not entirely clear why results were different in this study but authors proposed that compared to their study group, other published studies tended to involved younger participants with shorter disease duration and a greater number of scalp microneedling sessions. The authors wonder whether factors in their study like older age of patients, higher balding severity, and a longer disease duration could have led to  a failure of patients to achieve benefits.  

Even though the authors did not show benefit for microneedling, the authors point out that not all published studies, in fact, have shown that microneedling alone improves hair

A 2013 study the Lee et al showed that microneedling worsened hair density in female patients. This was a  scalp-split study in women with female pattern hair loss which compared isolated microneedling to combined microneedling PLUS  growth factors. After 5 weeks of weekly treatment, there was an improvement in hair density on the side treated with mincorneedling plus growth factrs, while the side treated with isolated microneedling showed worsening of hair density.  

Despite this there are several published studies that do propose that micorneedlign along is effective. A 2020 study by Bao et al showed that microneedling was similar if not superior to topical minoxidil and the combination was even more effective.

Conclusions

We are still in the early days of understanding scalp microneedling. Studies like the Kakizaki et al., 2023 study are important to remind us that not all studies show benefit of microneedling and a proportion of patients probably get worse (and lose more hair) on account of doing the procedure. There are no standard protocols to microneedling. The Kakizaki et al., 2023 study is important to  remind us that we need to study long term microneedle benefits too and that it is possible that a patient benefits after a few months only to lose any long term benefits thereafter. That needs to be studied!

It seems clear that microneedling combined with various drugs may allow the agent to get into the skin better (improved transdermal drug delivery) but that this is a different research question that isolated microneedling alone.

Further careful studies with long term evaluation are needed.

REFERENCES

Kakizaki  P et al. Efficacy and Safety of Scalp Microneedling in Male Pattern Hair Loss. Skin Appendage Disord. 2023 Jan;9(1):18-26.

Dhurat R, Sukesh M, Avhad G, Dandale A, Pal A, Pund P. A randomized evaluator blinded study of effect of microneedling in androge- netic alopecia: a pilot study. Int J Trichology. 2013;5(1):6–11.

Bao L, et al. Randomized trial of electrodynamic microneedle combined with 5% minoxidil topi- cal solution for the treatment of Chinese male androgenetic alopecia. J Cosmet Laser Ther. 2020;22(1):1–7.

Young Bok Lee et al. Effects of topical application of growth factors followed by microneedle therapy in women with female pattern hair loss: a pilot study. J Dermatol. 2013 Jan;40(1):81-3.