Excited that I was selected to participate in this trial (https://clinicaltrials.gov/ct2/show/NCT03354637). Thought I'd share my journey blog-style since there was no NDA included in anything I signed or was told. I'm a guy in the 26-35 age range. Just in case I'm going to be vague about some details and am going to post on a different timeline than the one I'm actually on (e.g., I'll be posting about week 2 when really I'm on week 4, etc).
The topical solution is a clear serum. I use a dropper to suck 1-2mL out of a large bottle and rub it into my scalp twice per day. It's thicker than water and more viscous than I'd expect. Like a VERY thin mucus. Leaves almost an oily residue on my scalp and remaining hair which isn't pleasant, and after a few minutes becomes tacky to the touch. It fully "dries" in about 1.5-2 hours in that it loses a lot of its tackiness but still makes my scalp feel kind of greasy to the touch. Almost wish it was a normal cream, but I suppose this is necessary to ensure the drug can get through the skin and to the hair follicle.
The drug is a JAK inhibitor, I'm not sure which brand. There are three options/strengths and neither I nor my dermatologist know which one I've been assigned: Placebo (no drug), Low Dose (~0.12%), and High Dose (~0.47%). Some of the other participants at my location started in the spring and my dermatologist indicated that they suspect one person has a placebo because she is not showing any results, but the other patients are showing improvement. We didn't get into specifics of what "improvement" means. The pessimist in me thinks I'll be on the placebo for sure, but I can hope.
In this post I'll talk about the first two visits. Visit #1 was screening, Visit #2 I was given the drug for the first time and shown how to apply it. During Visit #2, I was chatting with the doctor. I asked him about the trial so far. He said Aclaris has had to expand the inclusion criteria twice because they've had so much difficulty recruiting people. He seemed to think that this drug is < 2 years away from hitting the market, which is really cool. The doctor's office staff seems to think this stuff really works based on the others in the trial.
My thoughts from my first weeks is:
I have to say I'm a little anxious. My SALT score was ~50% hair loss. That almost knocked me over to hear, as I gave up on dermatologists 5 years ago after having every kind of treatment imaginable and none of it working. Staring at my scalp every day I never would have thought I had lost half of my hair. Kind of like slowly gaining weight over time and then one day someone shows you that you're 70 pounds heavier than you were in college. I've had AA for 12 years now, and this is the worst it's ever been. I would say my "normal" loss historically is in the 25-35% loss range. Over the years, I've grown my hair longer in areas above my patches, and use hairspray to let that hair cover the spots and hold it in place. I know this "curtain" of hair has been getting thinner on one side to the point that you can see through to my scalp. Since May I have been applying eye shadow to my skin to keep the pale white skin from showing through. I wish they made foundation in jet black; eye shadow is not ideal to cover such a large area. I've been getting more and more desperate as hair fell out. Had I not qualified for this drug trial, I think I'd have shaved my hair off. The "map of the world" look terrifies me to think about. I think I could make it work if I picked up and moved, but walking into work and seeing the same people I've seen for years with a sudden change? The looks, the comments, I don't think I can do it.
Of course now that I am in the trial, I'm not sure how my intricate hair styling technique will fare, as I've never had to "style" my hair during the first days on the medication thanks to vacation I already had planned in an area where I can wear a hat. Will the tacky residue work with the eye shadow (heck maybe it'll make it apply thicker)? The serum ends up getting into my hair a bit and making it wet/greasy. I'm really worried that I won't be able to be on the trial AND continue my styling. But to come this close and still have to shave my head... I have to figure out a way to make it work.
Lot of anxiety. Lot of details I need to figure out. The doctor said that if I am on the non-placebo and if the real drug works for me, it will be ~8 weeks from the first treatment before I see any regrowth based on his other patients in the trial. I still run my hand through hair that's still there and see some fall out, same thing in the shower. So the shedding hasn't slowed. Maybe that means I'm on the placebo, maybe it means that the drug takes more than just a few days to start working. I'm not reading into it.
More to come!
have you been on the trial for the same drug as 5DH?
Impossible to ever say for SURE I'm on low dose. But, my doctor was allowed 6 patients, and filled all 6 slots (2 placebo, 2 low dose, 2 high dose). Two patients have had no results at all. Two have had significant regrowth. So he suspects given my vellus hair growth that isn't developing very fast, that I'm on low dose. It's entirely possible that someone with no growth is just not responding to the medicine, or that someone with a lot of regrowth has the placebo and is naturally regrowing hair. We're just assuming.
Wow! Thanks for the really detailed explanation of what you’re going through. Sounds to me like it only works for people with AA, They are advertising a new drug trial for alopecia areata in my area which is Portland Oregon. The fact that I have had alopecia totalis for 50 years means there is no cure for me. But let’s hope this is a great cure for those with alopecia areata. Also check out the discussion on probiotics and supplements turning off your auto immune condition. Work from the inside out instead of the outside in or do both! What we would all give for a great head of hair!
I think for AT/AU you would want the pill form since it's systemic. I would say it SEEMS like it works for people with AA. No results to get excited about from me yet after 4 months...
Hey all - another month!
In my mind progress has slowed, although my doctor is still encouraged. He seemed to think the white (vellus) hairs had progressed. The areas where I've had vellus hairs for about 3 months now have been growing longer. None have taken on pigment to indicate terminal hair growth. He is just most convinced that I'm on the low-dose drug. It does seem that the vellus hair is now on about 2/3rds of my patchy areas.
Honestly, not a whole lot else to share. In another month I'll get rolled over to the open label where everyone is on high dose. My prayer is that it'll really start to make a difference at the higher dose and get some real hairs growing.
From a trial procedure standpoint, evidently the FDA has a few more boxes to check before that high-dose, open label trial begins -- my doctor doesn't even have the drug yet while they wait. We are all hoping after another month goes by it'll be ready. It'd be pretty disappointing to go back in a month and be told I'm off the low-dose and the high-dose isn't ready yet!
December/January Update - LAST TREATMENT
I missed last month's update, and I apologize. Honestly, I had nothing to report. My trial has concluded. The result is that I'm probably about 60% hair loss (it's gotten worse over the course of my treatment, although I'm sure the drug didn't make it worse). Of the 60% of my scalp that's bald, I have peach fuzz growing on about half to two-thirds of it. Maybe more, hard to see. The doctor is pretty convinced that I had the low-dose drug, which is about 12% medication in solution. I ended up shaving my head, which was a massive change for me, and honestly it's been great. What got me to take the plunge is everyone posting that they wished they'd done it sooner. I heartily agree!
Now for the good news. Acclaris is rolling everyone into an Open Label study of the "full strength" topical solution. This is something like 46% medication in solution, compared to the 12% that I was on. My doctor told me that I should see results - literally a full head of hair - within two months. Isn't that crazy? I can't wrap my brain around that being an actual possible thing that could happen to me after over a decade of hair loss. I'm taking some good "before" pictures to have on hand :)
One patient of my doctor's was on the full strength stuff. He said this guy was just like me - over 50% hair loss. He grew it all back, but because of the trial rules, he had to go off the medication for 60 days before he was rolled into the new study. By the time two months was up, he was losing his hair again.
So, what we're talking about here is a lifelong drug basically, that masks your symptoms but AA will always be lurking under the surface. The positive is that it's a topical application so basically no side effects. Some people may have experienced dry skin or irritation, it was all fine for me. But the negative is... will this drug be affordable? How will insurance companies react? And how long until it's approved? Evidently, Pfizer is conducting the exact same study, so maybe since they're a bigger company than Acclaris they can throw some weight around at the FDA to get this stuff to market.
I am going to make a new thread for my new study! Especially since the effects are supposed to be super positive. High hopes!
thank you for the update!
how have you been managing with applying the topical solution to areas of your head that have hair? my concern with topical treatments is that they are reactive, not proactive. if you've got a good head of hair it might be hard to find and treat new outbreaks before they get very large and noticeable
Well I made the decision to shave my head in December. That makes the application a lot easier. The only side effect I've experienced is that the topical solution is a bit slimey. It's thicker than water, but not as thick as even a very thin mucus. I don't know what to compare it to. All I know is, I try to put it on at least an hour before bed so it dries before my head hits the pillow.
Before shaving my head, my routine was literally waking up an extra hour early in the mornings, using hair clips to hold my hair up away from areas where I applied the medicine (my hair was long to cover the bald spots). I'd then wait about 25 minutes - watched a TV show - for the medicine to mostly dry. It does dry eventually. Not that it had any impact on my hair other than being kinda slimy...
To your point about proactive vs. reactive, this is definitely a treatment not a cure. I'm not sure there will ever be a cure in our lifetimes. From my understanding, a cure would involve changing your immune response, which gets into a genetic conversation right? Yeah...
But I do think it's a lifelong treatment. I'm doing it twice/day right now. Perhaps they'll eventually say for "maintenance" you only need to do it once/day. I have no idea. The other thing I'll say is, they've told me I should start seeing all my hair come back in two months on the new drug. If a patch develops and you jump on it immediately, the drug may slow or halt the progress in an "active" phase. I don't know the answer to that. The doctor did tell me that someone went off the drug for two months and all his hair started falling back out again, so I do believe, as I said, this is a lifelong treatment like people who take a pill every day.
I also know that hair absorbs the stuff. In the mornings when I shave my head, I can cover my whole head with 0.75 mL. If I don't shave the next day, I find that I need almost 1.5 mL. Just the 24 hours of stubble (and 50% of my head is bald anyway...) gets that much more absorbent. So frankly I'm not sure how someone with a full head of hair can apply this without needing to use at least 4 mL and it gets their hair kinda greasy. You'd almost have to apply it like a root touchup and try to massage it directly into the scalp trying to minimize hair contact.
And that gets me thinking about cost. Will this be affordable even with insurance? What about those people who need to use more or less of the medicine because of their amount of hair? I hate the idea of an effective treatment being out there that some people can't afford. Based on US patent laws, I believe it'll be several years before a generic would be available. The smartest thing might be to keep your hair short even if you have a full head of hair :) But that's a worry for another day.
Good luck with the stronger dosage.
That's great news!!! I cant wait for an actual treatment for Alopecia to come out, ive had alopecia since i was 13 and being 29 now, im hoping theres something by the time im 30 lol. I gave up on xeljanz since I don't want to take it the rest of my life. All the hair i grew back while on xeljanz fell out after a few weeks therefore its just not worth getting back on. Did your doctor provide a timeline as to when this might be available?