A Deeper Look at Hair Loss: The "Big Three" and the Hype of Microneedling
For anyone who has ever stepped into the world of hair loss culture, you've likely heard the term "Big Three." In the community, this usually refers to the optimal stack for preventing hair loss: finasteride, minoxidil, and a ketoconazole shampoo like Nizoral. While the first two are clinically proven, with unquestionable efficacy and safety, many have wondered if a dandruff shampoo truly deserves to stand alongside these pharmaceutical titans. The research on ketoconazole for hair loss is limited, and because of this, many have advocated for replacing it with another treatment. One popular option that often comes up is microneedling, also known as derma rolling.
Personally, I don't think we need a "Big Three" at all. Finasteride and minoxidil are outstanding enough on their own, so a "Big Two" works perfectly well. For many, even a "Big One" would be fine, as finasteride alone has been proven to stop and reverse hair loss in over 90% of people, both in the short and long term, even after 10 years of use.
Now, let's talk about microneedling. I have made videos on this before, and while I know it is a heavily hyped therapy, I believe it is a bit overrated. Most of the research on microneedling is done in conjunction with other treatments, usually minoxidil, and the studies often lack control groups. This makes it impossible to see how effective microneedling is compared to just placebo.
Let me summarize a typical study from 2018 that illustrates this. In the study, 68 men with Norwood 3 and 4 androgenic alopecia were randomized to receive either 5% minoxidil alone or 5% minoxidil plus microneedling. After 12 weeks, increased hair counts were seen in all patients treated with the combination, while the minoxidil-only group showed increased hair counts in only 76% of subjects. Based on this, it appears that microneedling might increase minoxidil efficacy. But we don't have any human studies that show microneedling alone does anything for hair growth without minoxidil. Are we just improving minoxidil absorption by poking holes in the scalp?
Another issue is that minoxidil's effectiveness depends on the presence of a sulfur transferase enzyme on the scalp. Since this enzyme wasn't measured in the subjects, it is possible that the group using both treatments were simply better responders to minoxidil than the group using it alone. Their added benefits could have just been from the minoxidil itself.
There is a fascinating Chinese study from 2018 that gets around this design problem. In this study, they compared 5% topical minoxidil applied to one half of the scalp versus 5% minoxidil plus a form of microneedling called fractional radio frequency microneedling to the other half of the scalp. This was clever because each patient was its own control and treatment group. The fractional radio frequency technique delivers radio frequency energy through needles, supposedly causing deeper tissue injury and making it more effective than regular microneedling.
However, the sample size was very small, only 19 patients. Hair counts increased in both sides of the scalp, though there was a slightly greater increase with the combined therapy. The most frequent side effect was pain, with an average pain level of 3.63 out of 10 on a Chinese pain scale. This is considered moderate pain, at least enough to be distracting. This study reinforces the notion that microneedling can be a weak adjunct to minoxidil, but it does not validate that microneedling alone is effective.
On the other side, there is evidence that needling the scalp alone does not affect hair growth. A randomized double-blind study compared repeated scalp injections of platelet-rich plasma (PRP) with a control group that received repeated scalp injections of saline. Hair growth was seen in the PRP group, but no growth was seen in the group that just got needling with saline injections. The authors explicitly stated that it was important to demonstrate there was no difference in the evolution of androgenic alopecia in the group treated with saline injections, and their results suggest that the needling had no effect on hair parameters.
The current state of the art for microneedling is that evidence is lacking that it has any real effect on hair growth by itself, despite some theoretical support and data from mice. At best, microneedling may be a weak adjunctive therapy. Frankly, I don't think it's worth the pain, especially since treating androgenic alopecia is a lifelong commitment.
The Rise of Fancy Microneedling Devices: The Case of Follica
Despite the lack of data, this hasn't stopped companies from cashing in on the hype. The market is now oversaturated with microneedling devices. New innovations are being researched to stand out, and one of the latest hot products is called Follica.
When I first checked their website, it looked really fancy, like a plant fertilizer company. Upon further inspection, it is just an overpriced microneedle device. Their website lists a pilot study published this year, titled "A Pilot Evaluation of Scalp Skin Wounding to Promote Hair Growth in Female Pattern Hair Loss." Disappointingly, like all studies on microneedling so far, this is a very small study with just 11 subjects, all women aged 25 to 70 with mild to moderate female pattern hair loss.
Two of the women were also on oral spironolactone, which is known to work for female pattern hair loss, bringing the subject size down to nine. The subjects underwent six treatments over three months with the "Follica Hair Follicle Neogenesis Device." The company markets this as a "proprietary powered microneedling device," which is just a fancy way of telling us to mind our own business if we are interested in how it works. This is not a good first impression.
All subjects were given a topical anesthetic before each session, so this is clearly not a pain-free device. Like all other microneedling studies, these patients also got 5% topical minoxidil foam applied every night. And there was no control group. Is there some law against designing a study that compares microneedling to no therapy? For all we know, the results here are just because of minoxidil.
The endpoints were photographs and patient-reported improvement after four months. Ten of the 11 women reported improvement. One thought their hair was significantly better, six were slightly better, and three were moderately better. Since they were all using minoxidil, this improvement is not surprising. The Sinclair score decreased on average by 1 to 1.5 points.
The procedure itself was not painless. Even after the subjects slathered their scalps with topical lidocaine, a powerful anesthetic, the average pain score was still 6.4 out of 10. A score of 6 is considered moderately strong pain that interferes with normal daily activities and causes difficulty concentrating. A score of 7 is pain that dominates your senses. So the average pain was just barely below 7, and some patients had worse. There were also headaches, bleeding, and redness. This Follica device sounds pretty abusive. The investigators classified the discomfort as "uncomfortable but tolerable," but it's easy for them to say when they aren't the ones having their scalp beaten.
What other research is there? On their website, they announced a 44% improvement in hair counts in another pilot study from 2019. This study is not yet published. It involved 48 men with Norwood grades 3 to 4, and there were three treatment arms looking at different frequencies and numbers of treatments. Once again, the treatment was combined with a topical drug, undoubtedly minoxidil. Across the three arms, the improvement was 29% overall in hair counts, though in the best arm it was 44%. This isn't all that great, especially since it was combined with minoxidil, which we know works. They apparently didn't even bother looking at the treatment by itself. A Phase 3 study was supposedly initiated in 2020, but we haven't heard anything since.
So what we have is a fancy powered microneedling device that has only been tested alongside minoxidil. It is impossible to know if it really stimulates stem cells or is just a means to improve minoxidil absorption. It sounds pretty painful, even more so than a regular derma roller, and will likely be very expensive. If the company is really convinced their device is effective, why not use it as a standalone treatment? Why not compare it to minoxidil or finasteride? These treatments are likely competitors. If you want to make a name for yourself in the hair loss industry, you should be able to show how your product compares on its own, not just in combination with existing treatments. This doesn't show much confidence from the manufacturers.
In the end, Follica looks like it is trying to cash in on the microneedling craze. It may convince impressionable people that it is more effective than any other device that punctures holes in your scalp. But the bottom line is that microneedling's evidence is already flimsy at best. More research needs to be done on microneedling alone to see if a fancy device like this is even justified. Maybe the Phase 3 study will have a better design, including a control group and a group that uses Follica alone. But I get the impression those studies will have all the same flaws.
For these reasons, I say forget about the idea of a "Big Three" altogether. Maybe one day we will find a treatment worthy of being compared to the giants like minoxidil and finasteride. There are promising treatments on the horizon, like the Wnt pathway drugs and topical anti-androgens. These treatments are much more likely to earn the honor of being in the "Big Three" than the microneedling devices we see today. So go ahead, throw your derma roller in a paint bucket, and stick with finasteride and minoxidil for now. I threw mine out years ago and didn't lose any ground. Good riddance to that medieval torture device.