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!
About 5 weeks into the trial at this point. Hardest thing to do is wait, not knowing if on placebo or not. Looks like I am NOT on placebo though! At my last visit, the doctor noticed white hairs popping up all over the place even though they told me 6-8 weeks minimum before I'd see anything at all. I shrugged this off saying doesn't this happen a lot and not always turn into terminal growth? They said this is what happened to their other patients on the trial who had the drug though. Evidently, your hair will come back white - sounds like for a few MONTHS (ugh) - and then regain pigment right around the 4 month or so mark of the trial.
AA has made me very pessimistic but hey, there are definitely white hairs in places on my scalp that haven't seen a hair in a decade, so that is kind of exciting.
I was also told that there is an application in front of the FDA right now to open up the trial more broadly as an "open label" study, awaiting approval from the FDA. That would mean more access to this stuff - and I think they'd remove the placebo and low dose options??
They've also changed the protocol. Where before they wanted me to carefully measure 2mL of liquid and apply on the patches, they now want me to apply it ALL over my scalp. The thought being there may be some areas affected by AA with no symptoms. I guess that makes sense, you could "chase" the patches all around you're scalp.
In terms of coping with the drug, only side effect is that my skin is starting to get flaky in some areas with regrowth. Odd. As I said in the OP, the drug is a clear solution that leaves a residue. I don't shave my head; I still have long hair to try to hide the bald spots. To keep this stuff from gunking up my hair in the mornings, my routine is shower, blow dry, put my hair in hair clips (LOL), and then apply the meds. I then wait about 20 minutes for it to dry enough that it won't make my hair wet and greasy if it comes in contact with it.
More to come! Hopefully this really is good news for me - and for those waiting on an effective treatment.
Nice! I will look forward to more post! I was told about the “widening of AA salt scores”. I was told it was lowered to 15% salt! I am over 50% and will find out more in the coming weeks. Thanks!
Another month. Time is really flying by when you're basically counting down to each appointment. My doctor seems encouraged. My SALT score hasn't changed from about 50% hair loss, but the vellus hairs sprouting up as a result of the drug trial are expanding and covering more area. Since they're not terminal it doesn't affect the SALT score so that probably won't change much from appointment to appointment. I would say I have 50% normal hair, 15-20% vellus coverage, and 30-35% still bald. But let's be real, vellus is basically nothing. It doesn't help me hide my patches, it's transparent, white hair. The research tech who is my main point of contact on the trial keeps saying how exciting it is that I'm going to have half brown and half white hair. Me? I don't consider that a win, really. He did say, though, that based on another patient further along in the trial, these hairs will eventually turn brown. I'm guessing I have a few months to go before that happens. And then for the areas that don't even have vellus hairs yet... it's like each follicle is on a different timeline, some faster and some slower. To get back to 100% "normal" - if that ever happens - might take a long time. Maybe a year?
He did also say that they're rolling everyone from the current trial onto another trial once the FDA greenlights the next stage. They're just waiting on confirmation. Everyone will get real medicine (no placebos) at whatever dose is approved by the FDA - low, high, or somewhere in between. So now my trial is 6 months of medicine, two months off (I think to see if it takes or if shedding starts again), then on again for at least 9 months for the second part. I'm just thinking why do I have to go off it for two months! Maybe that will get changed, too. xD
They also said the trial instructions have changed. Whereas before I was carefully measuring 2mL twice/day and applying to my patchy areas, they now want it applied on my entire scalp once/day and in the patchy areas only for the other application. The thought is that some hairs might be affected by AA but just haven't fallen out. That makes sense, otherwise you could just be chasing patches around your scalp.
My mental state now is that while this medicine seems to be working so far, it's a slow, slow crawl. I'm fully preparing that I won't be back to normal until summer, if I ever get to 100% regrowth. Still a lot of other questions, like will the medicine eventually work on the areas that don't have ANY vellus hairs popping up? The areas that have vellus hair are areas from my most recent episode. I've had patches that have been around for several years that aren't responding. Will it just take longer or? Or is the medicine not going to be effective?
Going from 50% SALT to 25% is definitely an improvement but I probably need < 10% to regain any semblance of confidence in public. At 50% I'm using eye shadow to cover patches. At 25% I can probably just go back to growing out my hair strategically and using hairspray. But I haven't felt normal in 12 years. I don't even know what that would be like. Something like standing up out of a wheelchair on your own two legs.
thanks for the update and for subjecting yourself to the trial for the rest of us!
I tried the cream from the Philadelphia pharmacy 2 years ago for 5 months and it did not work.It was made from Xeljanz and a cream that tingled slightly when you applied it don’t believe there were any clinical trials for it.You did need the Doctor to call it in.My Doctor said it did not work for any of her patients.I wonder if your cream is stronger,or they found a better way for it to be absorbed,do you know if it’s made from xeljanz or ruxolitinib or something completely different.Would cream come on the market sooner than a pill if it works?If it does work I would think you would have to use it all the time or have a relapse.
I think OP is on a trial for ATI-50002/ATI-502 which is a separate JAK inhibitor from Aclaris that is being developed specifically for alopecia areata
This is totally different, I don't have a cream. This is a topical solution, with a consistency somewhat thicker than eye drops and 100% clear. This absorbs deeper than a cream would, creams (traditional white paste) really don't go deeper than the top layer of skin.
My doctor said this is xeljanz but for all I know he could have been speaking quickly, it could be the generic not necessarily the brand name. Same active ingredient though I'm sure.
To the statement "I would think you'd have to use it all the time or have a relapse" I think that's what they're trying to evaluate. Obviously this is a treatment not a cure. You can't really cure your immune system going haywire with today's medicines, all you can do is fight back (or destroy your immune system... steroids). So, after being on the medicine twice/day for 6 months, they're going to take me off for two months and see what happens.
Right now I'm doing twice/day doses, they're probably first going to figure out if it even works, then which strength is the smallest that's still effective (low dose vs. high dose) and then frequency. Maybe it's something where you need to apply twice/day until you achieve full regrowth, then once/day or every other day or once a week for maintenance. But I'm sure it's a long-term medicine if you want to avoid shedding.
What does seem evident is that you can't apply it as a response to an "active" AA phase and hope to stop the loss in its tracks, since it takes weeks to start being effective. I don't know about you all, but when my AA moves into active shedding, a lot of loss occurs in the first month.
But all that said, again, the first steps is answering: is this medication even safe and effective? If yes, perhaps it can be adapted to an injection that would be more immediately effective or something. Who knows.
> speaking quickly,
lol exactly what you want a doctor to be doing when putting you on experimental medication, right?
One thing I've noticed with the topical xeljanz (biohair x) we've been using on my son is that if I see a new spot develop and I start putting the biohair on it immediately, it will start growing hair again inside of a month. where the areas that were previously affected for longer periods are taking longer to start growing back.
Why is this topical treatment going through a clinical trial and the cream from the Pennsylvania pharmacy all you needed was a doctor to call it in?
if you look at the trial information that OP linked to this is actually a different medication, ATI-50002 (ATI-502), whereas the stuff from Pennsylvania is Tofacitinib blended with a cream or ointment.
ATI-502 is intended to have a better safety profile than tofacitinib and is being developed specifically for dermatology cases (alopecia, vitiligo, psoriasis)
I think the cream is just something the pharmacy makes right? Just crushing up oral medicine and mixing it into a cream compound (I am certainly oversimplifying). There's no reason to think that will actually do anything and there's nothing proving it's effective. Kind of like grinding up a Centrum vitamin and snorting it.
The clinical trial is an entirely new vehicle. Again, it's not a cream.
Also Chris I think ATI-50002 is different than 502. I could be wrong about that. They're definitely separate trials, at least. Could be the same medicine but I thought they were different.
any new updates?