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Clinical Trial Blog: Topical AA Treatment
Hi all,
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!
Replies to This Discussion
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Permalink Reply by singh on
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Hi football fan,
Is that tablet or topical to be approved you think ?
Thank you
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I bet topical will be approved first and will be the cheapest.The topical I used from the Pennsylvania pharmacy was around 350$ a tube lasted about 1 month.
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Permalink Reply by 5DH on
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October Update
Hi all,
Another month. Wow. Well, 5 weeks.
Thanks for all the engagement in this discussion, I'll always answer as many questions as I can!
This month I guess I'm happy to report steady progress. I am still at right around 50% hair loss, but I would say the 50% that's bald about half of that (so 25% of my head) is covered in vellus hair. The hair keeps growing longer and gradually more area is being covered. The doctor thinks I'm on the low dose (there was High Dose, Low Dose, and Placebo) because he has another patient who is apparently regrowing much faster than me. Hey - better low dose than placebo, right?? I'll take it.
I was also informed that the test guidance has changed. The FDA approved an open label for the High Dose. Cool! So after two more months of low dose, I get rolled into the new open label study and switch to high dose. Not sure how long, they said maybe 6 additional months (8 more total). Yet to be determined.That the low dose amount that I'm on is moving so slowly, I suspect that I won't see much more improvement in the next two months.
The doctor keeps asking me if I'm excited about the peach fuzz/vellus hairs coming in. He is excited for me, I still shrug. For me, clear hair is the same as a bald head. I still need to cover it and use makeup to hide it. He thinks the hair will start to gain pigment soon. I suspect it will be in the same order that the vellus hairs came in, so it'll start in one area and spread out.This is so slow, I can't help but think IF it does work and my hair all comes back, it won't be until springtime 2019. And a couple months after that they'll end the new study! You guys I am already dreading the relapse of the hair I don't even HAVE YET. How crazy is this condition on our psyche?
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how is it going
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Still nothing much to report. Some white fuzz, no terminal/normal hair. As I commented on another person's post, I believe my hair loss has actually gotten a bit worse as the trial has continued. I don't think the drug is making it worse, but I do think the drug isn't having much of an impact in "winning the battle". For 6 weeks I have been applying the drug to my whole scalp, including areas where I have normal hair. The point of that is to stop any hair loss that might occur in areas that might develop a bald patch. Despite my doing that, I am convinced I am still losing hair. So that has be bummed out. I suspect that I'm not going to see any real improvement until they move me from the low dose to the high dose at the end of the year. And that's if the high dose works for me.
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I will suggest you to try natural treatment, lifestyle change, diet, exercise. I have written in my blog what I have done to regrown my hairs after 3 years of suffering from Alopecia Areata with more than 15 patches.
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Good for you it worked but a lot of us tried that first and it didn’t work.
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Yeah this was the first thing I tried. Back when i was in college and developed AA, my mom took me to a homeopathic doctor. He had me stop gluten and dairy, and tried a million supplements (honestly, the "natural" doctor cost more per visit than a medical doctor, because it's not covered by insurance - nor are the supplements they prescribe.)
Eventually I realized it was all a scam. After months of no progress, he finally said "you know, the immune system is really the last big question mark about the human body, we don't really know how to control it very well." So... you couldn't have told me you had no idea what you were doing on the front end of this?
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I also spent thousands on weekly visits and supplements,teas,acupuncture etc.Next time you see your Doctor 5DH can you ask him if this treatment wil be available in the not so distant future.
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Hard to say really. They update me on the trial every time I go in. Opening it up to a wider group is a really good sign. The soonest realistic timeframe is probably 2020, as that trial's results wouldn't even be finalized until mid-2019 at the soonest.
That said, a word of caution... I have been on this treatment for 3 months and other than some white fuzz on PART of my bald areas, nothing has changed. White fuzz is not success unless it turns into terminal hairs - and regrows over a substantial part of my scalp. In fact, I believe my hair loss has gotten a bit worse as the trial has continued. I don't think the drug is making it worse, but I do think the drug isn't having much of an impact in "winning the battle". For 6 weeks I have been applying the drug to my whole scalp, including areas where I have normal hair. The point of that is to stop any hair loss that might occur in areas that might develop a bald patch. Despite my doing that, I am convinced I am still losing hair.
Granted, as I mentioned in my last post, my doctor and I are pretty confident that I am on the "low dose." I'm supposed to move to High Dose, which I believe is triple the concentration (from like 0.12% to 0.43% or something like that) starting at the end of December. Perhaps that will yield a better result. At this point I'm convinced that low dose is not really effective, so I want to fast-forward to December when I can get on the good stuff.And I really hope that works...
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Thanks Good Luck!
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I was just wondering how you and your doctor are confident as to what dose you are on. I just finished my six month trial and neither me nor my doctor have any idea if I'm on a placebo or a high or low dose of the trial medicine. I'm getting ready to start the extended trial soon which guarantees me the high dose. I was the only participant in the trial in my area and I still don't have a clue if I was on the placebo or high or low dose. I have had some regrowth but most spots would usually fall back out shortly after regrowth although a few have remained covered. It would be impossible for anyone in this trial to comment on regrowth or lack thereof as a result of medication that we aren't sure we are even on. Once this extended trial starts with the guaranteed high dose then I will post more definitive results. As we all know Alopecia is a very strange disorder.
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