From the FDA website: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label

Why might an approved drug be used for an unapproved use?

From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.

Quote

How many sessions of micro-coring willit take if it treats only 5%of the skin at a time?

IIRC, they've removed up to 40% of the tissue and still obtained scarless healing. But let's say 15% to be conservative. Over 10 sessions -- since the cores are taken at random, you'll have overlap, so say the cored area needs to be 1.5x greater than the actual surface area of the skin-- you should have complete scar removal. With 3-month gaps, 10 sessions can be done in 3 years. Even a 50% improvement in 1.5 years would be great.

7 hours ago, David4bay said:

I came just in the nick of time to see someone answer in the way i would have too. I think mysharon confuses these upcoming therapies and devices with the current "scar removal" treatments we have that at best work to make scars harder to see or better match ones skin colour.

But the scar has to be removed somehow, no? How do you imagine the 'scarless healing' therapies to work on scar tissue? Get applied on the scar and magic effect scarred skin -> scarless skin? How do you want to excise rolling scars or boxcars which are not surface level but deep and atrophic, where there is lack of skin? And how about extensive scarring?

21 minutes ago, k95 said:

From the FDA website: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label

Why might an approved drug be used for an unapproved use?

From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.

IIRC, they've removed up to 40% of the tissue and still obtained scarless healing. But let's say 15% to be conservative. Over 10 sessions -- since the cores are taken at random, you'll have overlap, so say the cored area needs to be 1.5x greater than the actual surface area of the skin-- you should have complete scar removal. With 3-month gaps, 10 sessions can be done in 3 years. Even a 50% improvement in 1.5 years would be great.

Health care providers may prescribe the drug off label but they do it on their own responsibility and at their own risk. It is not considered standard. If some complication happens, they can be legally prosecuted.Fda clerance is needed for the reasons I stated aboveproof of efficacy, safety and marketing.

No dermatologist would prescribe you Latisse for eyelash thickening because if they do and you get problems, which happens very often, it is the doctor's license on the line.

Do you have a link to the source of the 40% removal of tissue with the micro-coring? Cytrellis conducted studies on acne scars as well, two years ago. Any information as to why they didn't get fda approval for scars as well,and haven't even applied for it?

1 hour ago, nikkigirl said:

To see you people endlessly wait for a cure that never happens.....and i don't come here much anymore.

Good

@k95This is the video of the microcoring treatment on wrinkles,where the lady got 3 treatments with 5% coverage each time, overall 15%. I am really curious how you come up with 40% or 50% at a time, because I looked up again today and couldn't find anything. Do you happen to have insider info of some kind? Also, do you know what happened to the Cytrellis acne scar studies conducted 2 years ago? Cytrellis applied for fda approval just for wrinkles, not for acne scars. The studies didn't show good results?

"It reduces excess skin by about 5 to 10 percent, but you dont have any scarring, so if you do it 10 times, youve removed 30 percent of skin."

Can This New FDA-Cleared Technology Rival a Facelift Without Surgery? - NewBeauty

@mysharonthe paper: https://pubmed.ncbi.nlm.nih.gov/23357983/ 40% seems to be the upper limit but 10 - 15% probably has fewer risks, esp for older patients being treated for wrinkles.

My calculations for "10 sessions over 3 years" were still done with an assumption of 15%, which many people would be happy with.

Methods:Thirty-two 1 1-inch sites per flank received either 20 or 40 percent treatment coverage. Photographs were taken and punch biopsies were performed at days 0, 7, 28, 56, and 84. Biopsy specimens were evaluated for histology and collagen content.

Results:All treatment sites healed quickly, with no evidence of scarring or infection. Coring sites were easily identified and contained increased fibroblast activity and newly synthesized collagen. At 1 month, the papillary dermis and epidermis of the coring sites were up to 196 percent thicker compared with controls (p < 0.001).

22 minutes ago, k95 said:

@mysharonthe paper: https://pubmed.ncbi.nlm.nih.gov/23357983/ 40% seems to be the upper limit but 10 - 15% probably has fewer risks, esp for older patients being treated for wrinkles.

My calculations for "10 sessions over 3 years" were still done with an assumption of 15%, which many people would be happy with.

 

 

Methods:Thirty-two 1 1-inch sites per flank received either 20 or 40 percent treatment coverage. Photographs were taken and punch biopsies were performed at days 0, 7, 28, 56, and 84. Biopsy specimens were evaluated for histology and collagen content.

Results:All treatment sites healed quickly, with no evidence of scarring or infection. Coring sites were easily identified and contained increased fibroblast activity and newly synthesized collagen. At 1 month, the papillary dermis and epidermis of the coring sites were up to 196 percent thicker compared with controls (p < 0.001).

Thanks for the link.This study seems to have been published in 2013 however and it is not by Rox Anderson or the team at Boston Mass General Hospital, who developed the micro-coring device of Cytrellis. The official information is very scarce. I have read about 5% at a time or a small % at a time as higher % would mean more risk. We will live and see. The device isn't available at dermoffices on a large scale as of now. Hopefully, there will be some light on the mysterious acne scar studies, which seem to never have been published.

13 hours ago, mysharon said:

Thanks for the link.This study seems to have been published in 2013 however and it is not by Rox Anderson or the team at Boston Mass General Hospital, who developed the micro-coring device of Cytrellis. The official information is very scarce. I have read about 5% at a time or a small % at a time as higher % would mean more risk. We will live and see. The device isn't available at dermoffices on a large scale as of now. Hopefully, there will be some light on the mysterious acne scar studies, which seem to never have been published.

You'll need to read up on the previous pages to see what everyone has gathered here concerning micro-coring, personally it'd be the best for the scars i have. And a few excerpts from the scar studies on micro-coring were posted by me a long time ago, go through them.

On 9/16/2021 at 7:23 PM, mysharon said:

Isecond that! There are two many ifs ifs. Researchers will test all hypotheses, that's what they are paid to do. But at the current state of this drug's research they are faaar faaar away from any significant progressto using the drug for scar treatment purposes. Still on animal testing phase, still no definite results there. Moreover, pigs' skin is not human skin. Cleft lip surgeries are not acne scars. It will be decades untilthey can even come closer to fda approval for scars. IF it works at all. It all seems to be fitting more into the realm of science fiction than reality.

Microcoring which was into final stages of human testing and got fda-approved for wrinkles turned out to be a big disappointment for scar sufferers. We shouldn't put too much hope into something which is even more experimental.

You want to buy a drug which isn't even proven to work yet? No studies on human, no idea how it can be used, nothing. Why?

You clearly dont understand what offlabel use means but anyway thanks for your thoughts.

Btw the entire world doesnt wait on the FDA, that's an American problem. An approved drug thats already used safely in humans will not take decades to get the ok that satisfies physicians/dermatologist so Im not sure why you are taking such a pessimistic outlook on all of this.

Yes I agree we dont know what the results will be in humans yet but its promising so far and as someone else mentioned this is a highly regarded team of experienced researchers, not some pharma company looking for more suckers to make money off. Your view that it will take decades if it even works just doesnt make sense

6 hours ago, Sniffy said:

You clearly dont understand what off label use means but anyway thanks for your thoughts.

Btw the entire world doesnt wait on the FDA, that's an American problem. An approved drug thats already used safely in humans will not take decades to get the ok that satisfies physicians/dermatologist so Im not sure why you are taking such a pessimistic outlook on all of this.

Yes I agree we dont know what the results will be in humans yet but its promising so far and as someone else mentioned this is a highly regarded team of experienced researchers, not some pharma company looking for more suckers to make money off. Your view that it will take decades if it even works just doesnt make sense

No comment!  

You are aware that outside of the us there are drug regulating agencies as well? 

As I said, it is my view on things. I stated my arguments already, if you don't understand, nothing more I could do. Let's see when Verteporfin could be part of acne scar treatments.  Like it or not there are still years until both Verteporfin or micro-coring will be available to the average scar sufferer, if they actually work. You are really all dreamers here, speculating and day dreaming how still not proven treatments will give you scarless healing.

11 hours ago, David4bay said:

You'll need to read up on the previous pages to see what everyone has gathered here concerning micro-coring, personally it'd be the best for the scars i have. And a few excerpts from the scar studies on micro-coring were posted by me a long time ago, go through them.

Can you post link to the scar studies please? What did they conclude and why didn't Cytrellis apply for fda approval for scars?

Well, if you have a linear scar sure micro-coring could improve it with many sessions(as many existing treatments can, btw)but a linear scar isnot what the average scar sufferer has.

Ok. I found it. Well, 20 people(very few)with scars ANDstretch marks received 5-10% coverage (not 40%) treatment and got some improvement, not clear what exactly. No wonder Cytrellis didn't apply for approval.

5 hours ago, mysharon said:

No comment!  

You are aware that outside of the us there are drug regulating agencies as well? 

As I said, it is my view on things. I stated my arguments already, if you don't understand, nothing more I could do. Let's see when Verteporfin could be part of acne scar treatments.  Like it or not there are still years until both Verteporfin or micro-coring will be available to the average scar sufferer, if they actually work. You are really all dreamers here, speculating and day dreaming how still not proven treatments will give you scarless healing.

Whats the point you're trying to prove here these past few days? 

You came here with this wave of negativity and keep criticizing everything. 

What are we supposed to do? What does the thread say? "Scarless Healing". That's all we are trying to talk about, discuss future prospects and what not. Everyone here realizes that verteporfin may or may not work. Do you expect us to stay depressed about our situation and not research into future prospect on what may or may not work? Longaker has spent 34 years researching scar free regeneration so far. Sooner or later, it can be few years later or few decades later, but scar free healing WILL become a reality, we are just discussing future prospects here that's it. Take your "realism" or different "point of view" somewhere else please. It's tiring at this point. Just leave. 

Are we supposed to undergo current "treatment" that doesn't do jackshit except in some angled lighting?

Seriously wtf is your problem? 

8 hours ago, NagarNikku_ said:

Whats the point you're trying to prove here these past few days? 

You came here with this wave of negativity and keep criticizing everything. 

What are we supposed to do? What does the thread say? "Scarless Healing". That's all we are trying to talk about, discuss future prospects and what not. Everyone here realizes that verteporfin may or may not work. Do you expect us to stay depressed about our situation and not research into future prospect on what may or may not work? Longaker has spent 34 years researching scar free regeneration so far. Sooner or later, it can be few years later or few decades later, but scar free healing WILL become a reality, we are just discussing future prospects here that's it. Take your "realism" or different "point of view" somewhere else please. It's tiring at this point. Just leave. 

Are we supposed to undergo current "treatment" that doesn't do jackshit except in some angled lighting?

Seriously wtf is your problem? 

I don't understand you. You want to believe in some future treatment which is still at stage animal trials or some technology for wrinkles. It's a topic about discussing the potential of future therapies, right?  You want only like-minded people who will let you live in your delusion bubble? I'm sorry. I have scars too, but I don't lie to myself that these scarless therapies have any serious potential. I don't see any serious interest from dermatologists either. Maybe Verteporfin could be something like stem cells or PRF like add-on treatment to standard scar treatments which can help remodell the scars and give better results, provided it works in human skin that is, but in my opinion I don't see 'scarless healing' with existing acne scars. Micro-coring could be an option for darker skin types instead of lasers, but it won't be scarless either, will taky maaany sessions, and many years until it is widely available. I am interested in researching and discussing too. Why are you telling me to leave just because my comments don't fit into your information bubble?

And it will take years until you will be able to get any of these treatments, if ever, I sign with both hands under this, but you will believe what you want to believe

47 minutes ago, mysharon said:

I don't understand you. You want to believe in some future treatment which is still at stage animal trials or some technology for wrinkles. It's a topic about discussing the potential of future therapies, right?  You want only like-minded people who will let you live in your delusion bubble? I'm sorry. I have scars too, but I don't lie to myself that these scarless therapies have any serious potential. I don't see any serious interest from dermatologists either. Maybe Verteporfin could be something like stem cells or PRF like add-on treatment to standard scar treatments which can help remodell the scars and give better results, provided it works in human skin that is, but in my opinion I don't see 'scarless healing' with existing acne scars. Micro-coring could be an option for darker skin types instead of lasers, but it won't be scarless either, will taky maaany sessions, and many years until it is widely available. I am interested in researching and discussing too. Why are you telling me to leave just because my comments don't fit into your information bubble?

And it will take years until you will be able to get any of these treatments, if ever, I sign with both hands under this, but you will believe what you want to believe

if you call me believing in someone's decades of research  and being optimistic a delusional bubble, then that's okay.  Whatever helps you sleep at night. 

I still don't understand the point you're trying to prove, if you don't believe in scar less regeneration, why even bother reading this thread and replying negatively to everything, what exactly are you trying to achieve with this? You're interested in researching and discussing but all I see is pessimism and honestly it's very draining. Truth is, nobody knows, not you or me, or anyone else on this forum about the timeline of scar less regeneration, but what are we supposed to do meanwhile? We're just discussing what this thread exists for. You're right about things being extremely slow in the field of medicine, but the drug being tested for this is already safe for humans. What truly will answer the question is the result of the swine studies of verteporfin, and maybe the research on pigs won't go exactly how we want it to and none of us can control it. All we can do is stay optimistic about it.

Frankly if you're as pessimistic in real life, then your issues lies far beyond acne scars. I won't even bother replying to you anymore unless its something productive. It's tiring. Take care.

2 hours ago, NagarNikku_ said:

if you call me believing in someone's decades of research and being optimistic a delusional bubble, then that'sokay. Whatever helps you sleep at night.

I still don't understandthe point you're trying to prove, if you don't believe in scar less regeneration, why even bother reading this thread and replying negatively to everything, what exactly are you trying to achieve with this? You're interested in researching and discussing but all I see is pessimism and honestly it's very draining. Truth is, nobody knows, not you or me, or anyone else on this forum about the timeline of scar less regeneration, but what are we supposed to do meanwhile? We're just discussing what this thread exists for. You're right about things being extremely slow in the field of medicine, but the drug being tested for this is already safe for humans. What truly will answer the question is the result of the swine studies of verteporfin, and maybe the research on pigs won't go exactly how we want it to and none of us can control it. All we can do is stay optimistic about it.

Frankly if you're as pessimistic in real life, then your issues lies far beyond acne scars. I won't even bother replying to you anymore unless its something productive. It's tiring. Take care.

There you go. Yet another person to tell me that I am wrong about the results taking decades/ years, wrong about FDA approval, it is just my pessimistic take on micro-coring, or it is just my pessimistic outlook on life. It is what people usually do when they cannot bring up any facts, or arguments -attack you personally.

Have you read whatthe decade-long research is all about and do you know actually what the Professor is trying to achieve? Or is scarless healing to you synonimous with getting rid of acne scars???

Unfortunately, many are in a delusionalbubble regarding scarless treatments and dismiss everything which you don't like

So far I haven't written anything wrong, I have dealt with facts only while you have been wrong about 'scars being just scars', the 50% coverage at a time of micro-coring, one guy said it works for scars based on a weak study of 20 people with no specific results, then the FDA and off label use bullshit. Your level of naivity and cluelessness are astonishing. If I point out concerns and problems of the treatments, it is because I see them and wan to discuss themon the scarless thread, just like you do.

I write here out of interest, in the hope of finding something which could improve my scars, ask for information. I cannot do anything if the potential of these scarless treatments is small or that the facts are pessimistic, like it or not. Or that you have the facts wrong! Anybody is welcome to address the facts and issues I have presented and challenge them, it is what the thread is about. How about doing this for a change and leave my'pessimistic' views alone!

On 9/21/2021 at 2:05 AM, mysharon said:

There you go. Yet another person to tell me that I am wrong about the results taking decades/ years, wrong about FDA approval, it is just my pessimistic take on micro-coring, or it is just my pessimistic outlook on life. It is what people usually do when they cannot bring up any facts, or arguments -attack you personally.

Have you read whatthe decade-long research is all about and do you know actually what the Professor is trying to achieve? Or is scarless healing to you synonimous with getting rid of acne scars???

Unfortunately, many are in a delusionalbubble regarding scarless treatments and dismiss everything which you don't like

So far I haven't written anything wrong, I have dealt with facts only while you have been wrong about 'scars being just scars', the 50% coverage at a time of micro-coring, one guy said it works for scars based on a weak study of 20 people with no specific results, then the FDA and off label use bullshit. Your level of naivity and cluelessness are astonishing. If I point out concerns and problems of the treatments, it is because I see them and wan to discuss themon the scarless thread, just like you do.

I write here out of interest, in the hope of finding something which could improve my scars, ask for information. I cannot do anything if the potential of these scarless treatments is small or that the facts are pessimistic, like it or not. Or that you have the facts wrong! Anybody is welcome to address the facts and issues I have presented and challenge them, it is what the thread is about. How about doing this for a change and leave my'pessimistic' views alone!

How about keeping them to yourself , because ultimately they are people on here that stop living there lives because of the scarring they have in which scar free healing holds the key to changing their lives , who are you to come on here and shit on peoples hopes ? the scientists that are working on these technologies are vastly more qualified to talk about weather they will work on humans or not and not some no onethat wants to bring peoples morale down.

3 hours ago, Scarcure said:

How about keeping them to yourself , because ultimately they are people on here that stop living there lives because of the scarring they have in which scar free healing holds the key to changing their lives , who are you to come on here and shit on peoples hopes ? the scientists that are working on these technologies are vastly more qualified to talk about weather they will work on humans or not and not some no onethat wants to bring peoples morale down.

I only want to discuss and certainly the scientists are more qualified but I have a head on my shoulders and an opinion too and it is a public forum after all.

Well, it is not me who brings people down. It is the nature of scars, and the sh*tty treatments we have. I am just writing about some problems I am seeing with these scarless treatments.

I also would like nothing more but to believe that there will be some drug, you will just have to cut out the scars and doctors will see potential and start injecting it on scars' edges just because a pig study shows results and oh miracle 'scars are just scars' and scars be gone. But Iam not that naive.

Besides, I said that I see some potential in Verteporfin as add on (if it works) and in micro-coring (many sessions)in darker skin type, but no scarless healing ot close to perfect skin. If you care to read about the research, you will see that the research mostly focuses on how to prevent scars immediately after surgeries, or how to prevent scarring of organs, which is far worse than acne scars because it is life limiting and threatening.

People shouldbetter max out the current scar therapies because the future ones are still in the future.

43 minutes ago, mysharon said:

I only want to discuss and certainly the scientists are more qualified but I have a head on my shoulders and an opinion too and it is a public forum after all.

Well, it is not me who brings people down. It is the nature of scars, and the sh*tty treatments we have. I am just writing about some problems I am seeing with these scarless treatments.

I also would like nothing more but to believe that there will be some drug, you will just have to cut out the scars and doctors will see potential and start injecting it on scars' edges just because a pig study shows results and oh miracle 'scars are just scars' and scars be gone. But Iam not that naive.

Besides, I said that I see some potential in Verteporfin as add on (if it works) and in micro-coring (many sessions)in darker skin type, but no scarless healing ot close to perfect skin. If you care to read about the research, you will see that the research mostly focuses on how to prevent scars immediately after surgeries, or how to prevent scarring of organs, which is far worse than acne scars because it is life limiting and threatening.

People shouldbetter max out the current scar therapies because the future ones are still in the future.

Again , lets leave it to the scientists , also it isn't just acne scarring , but scarring in general , do you realize the life altering damage that is caused by scarring ? am not talking about your pot mark here and there , am talking about victims of fires , the skin so constraining that they have to smoother themselves in moisturizer all the time , if this was just an issue of looks than it wouldn't be a big deal , but it isn;t just that , if breakthoughs are happening now what makes you so sure it will be so long in the future ? again nothing of substance with you , just bullshit assumptions that something will not work , 3d bioprinting is gaining alot of attention.

31 minutes ago, Scarcure said:

Again , lets leave it to the scientists , also it isn't just acne scarring , but scarring in general , do you realize the life altering damage that is caused by scarring ? am not talking about your pot mark here and there , am talking about victims of fires , the skin so constraining that they have to smoother themselves in moisturizer all the time , if this was just an issue of looks than it wouldn't be a big deal , but it isn;t just that , if breakthoughs are happening now what makes you so sure it will be so long in the future ? again nothing of substance with you , just bullshit assumptions that something will not work , 3d bioprinting is gaining alot of attention.

I do realize the impact of scarring. I have been affected too .Do you leave it to the scientists or tell this just to people who disagree with you? So we are not allowed to discuss?

Burn victims can be treated successfully with a laser currently. It is called Scaar FX by Lumenis. Check the stories out.

I have written why IF these scarless approaches are proven to work at all, it will take years. I have written why. They haven't completed the pig studies or started the human studies yet, and a study usually takes a lot of time to plan, organize, conduct and complete. and again, the main focus on the research of Verteporfin is how to prevent fresh scars from becoming fibrotic. You'd better read the papers. But you believe, what you want to believe.

3D bioprinting yes, next we will teleport ourselves to Mars.

This is a Scarless healing Thread. Please dont waste our time with discussion about Lasers that have a long track record of doing buggerall for scars, any results you see are minimal and probably a result of swelling, I speak from experience.People want to remove their scars not improve them marginally and lose a lot of money in the messy process.

The momentum for scarless healing has gathered much more steam the past 5 orso years because of inferior current day treatments. Lasers and other such treatments are not sustainable anymore, they had their time in the lime light when they were the buzz word. People want more, want real results and the Industry is finally recognizingthis.

'The Scaar Fx was mentioned in reference to the burn victims, there are many successful stories of burn victims online. The Scaar Fx is not suitable for acne scars.

We will live and see what will happen to Verteporfin andthe other scarless healing treatments in a few years. Hopefully they don't fail miserably as Elastagen and all the previous high hopes.

1 hour ago, mysharon said:

'The Scaar Fx was mentioned in reference to the burn victims, there are many successful stories of burn victims online. The Scaar Fx is not suitable for acne scars.

We will live and see what will happen to Verteporfin andthe other scarless healing treatments in a few years. Hopefully they don't fail miserably as Elastagen and all the previous high hopes.

I agree that Verteporfin or whatever its called will take a few years , also no one is talking bout acne scars but diff type of scarring when it comes to Verteprofin, mostly surgery scars , whichis something diff. Theres one treatment -hope after another gone , people were so hopefully bout Microcoring2 years ago and now it looks like its just some skin rejuve treatment , i understand the scepticism or maybe should i say realisticapproach .

4 hours ago, Miro said:

I agree that Verteporfin or whatever its called will take a few years , also no one is talking bout acne scars but diff type of scarring when it comes to Verteprofin, mostly surgery scars , whichis something diff. Theres one treatment -hope after another gone , people were so hopefully bout Microcoring2 years ago and now it looks like its just some skin rejuve treatment , i understand the scepticism or maybe should i say realisticapproach .

Yeah. Have you seen the before afters of micro-coring for wrinkles? Does it look like scarless or wrinkle free? Iwouldn't say, there is slight improvement but the lady still has wrinkles. For scars it is even more questionable. Maybe in dark skin types, where lasers don't get recommended it could help though. Many sessions.

About Verteporfin absolutely, they are trying to get people scarfree from their cosmetically bothersome surgicalscars, and to prevent scarring of organs,which will be a huge success if they do it. They will be saving lives. That's what all the fuss is about. Maybe, just maybe, the drug could help with better healing after scar treatments if it indeed has such huge regeneration potential, but acne scars are old and often atrophic so people should really stay on the ground here.

I hate my stretch marks.

The reason there is excitement around Microcoring is because of its potential, nobody knows if it will 100% work but it already offers more hope than Lasers. It aims to remove unwanted tissue whereas Laser will only serve to manipulate and reorganize scar tissue, not actually remove it.

The photos from Microcoring that we have seen are only 1-3 treatments. It would be interesting to see after 10+ sessions of treatmentto acne scar or any scar really. The issue with Acne scars is thescattered appearance and accuracy to target them could take time.

57 minutes ago, Sniffy said:

The reason there is excitement around Microcoring is because of its potential, nobody knows if it will 100% work but it already offers more hope than Lasers. It aims to remove unwanted tissue whereas Laser will only serve to manipulate and reorganize scar tissue, not actually remove it.

The photos from Microcoring that we have seen are only 1-3 treatments. It would be interesting to see after 10+ sessions of treatmentto acne scar or any scar really. The issue with Acne scars is thescattered appearance and accuracy to target them could take time.

 

Ablative lasers remove tissue by evaporating it, hence the name ablative.