Shiseido Hair Loss Clinical Trial To Begin

[nameless]

"Where did you read it was a substantial dose?"

I read that years ago at numerous posts at Hairsite. It was the more credible posters who said it. They were very disappointed.
They said the dose was high. I think they used links to demonstrate their point. This was back shortly after the study results were publicized.

 

[nameless]

Permanent results is their aim and the new cells they inject replace damaged ones and protect hair from the effects of DHT. These new cells will be DHT resistant so it will be permanent. They've also stated that the injections will make the hairs return to normal function so the 10% could increase (but they only tracked growth and thickening for 6 months so that's yet to be seen).

Also they only did ONE injection that was not substantial it was a test for safety! the second trial is multiple injections, you cannot judge efficacy off a safety trial! I don't know how many times this has to be said

When they do phase 1 studies they are also looking for efficacy as well. No matter how many times you imply otherwise you won't make this untrue.

During phase 1 they are trying to determine the safety and effective dose in a low number of patients. They use a low number of patients in phase 1 to limit the number of potential injuries from the treatment. During phase 2 and 3 they use larger number of patients because they established some safety in phase 1. They are looking at efficacy and safety in all 3 phases.

http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

 

[jc3303]

When they do a safety study they are also looking for efficacy as well. No matter how many times you imply otherwise you won't make the opposite true.

During phase 1 they are trying to determine the effective dose in a low number of patients. They use a low number of patients in phase 1 so that if patients get injured from the medicine only a few will be injured. During phase 2 and 3 they use larger number of patients because toxicity is more likely to reveal itself as you increase the number of test subjects. They are looking at efficacy and safety in all 3 phases.

http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

that link says phase 1 purpose: safety and dosage, phase 2 purpose: EFFICACY and side effects.........

so you just proved my point

 

[nameless]

that link says phase 1 purpose: safety and dosage, phase 2 purpose: efficacy and side effects.........

so you just proved my point

No I didn't. You see what you want to see.

When they say they're looking for dosage they mean they're trying to find the lowest possible dose they can use and still get positive results without compromising safety. And of course this means they are monitoring efficacy.

They are monitoring safety and efficacy in all 3 phases. What do you think - do you think that after the phase 1 SAFETY study they stop monitoring for safety issues? Give me a break. They ARE watching safety and efficacy in all 3 studies. Histogen monitored for safety and efficacy in its' pilot study for God's sake.

 

[jc3303]

No I didn't. You see what you want to see.

When they say they're looking for dosage they mean they're trying to find the lowest possible dose they can use and still get positive results without compromising safety. And of course this means they are monitoring efficacy.

I'm not "seeing what I want to see" I'm seeing what is clearly stated on that link

of course they monitor efficacy but they're not aiming to get maximum efficacy in the first trial which is what I've been saying the whole time. The 2nd trial will see some participants get multiple doses so it will more than likely produce better results

 

[nameless]

I'm not "seeing what I want to see" I'm seeing what is clearly stated on that link

of course they monitor efficacy but they're not aiming to get maximum efficacy in the first trial which is what I've been saying the whole time. The 2nd trial will see some participants get multiple doses so it will more than likely produce better results

That link says they're testing for dosage in phase 1, and finding the proper dose includes finding the lowest dose that achieves efficacy. You're just taking advantage of the fact they didn't explicitly use the word "efficacy" but of course when they look into dosage they are looking for the lowest possible dose with efficacy. What do you think they mean when they say they are testing for the right dosage? Do you think they mean they are trying to find the lowest dose that builds the most houses or find the lowest dose that surfs the internet the best? When they say they are trying to find the correct dose they mean they are trying to find the lowest dose WITH EFFICACY.

And like I said, some of the most respected members at Hairsite said they used a solid dose when they did that study.

And the fact that you're saying that their future studies will "more than likely" get better results is all I need to read to know that you believe what you want to believe. Why don't you just declare that Replicel will give complete reversal of hair loss since that's what you want to believe? Oh wait, you are kind of saying that Replicel will give complete reversal of hair loss.

 

[jc3303]

That link says they're testing for dosage in phase 1, and finding the proper dose includes finding the lowest dose that achieves efficacy. You're just taking advantage of the fact they didn't explicitly use the word "efficacy" but of course when they look for the lowest possible dose they can use they mean they are looking for the lowest possible dose with efficacy. What do you think they mean when they say they are testing for the right dosage? Do you think they mean they are trying to find the lowest dose that builds the most houses or find the lowest dose that surfs the internet the best? When they say they are trying to find the correct dose they mean they are trying to find the lowest dose WITH EFFICACY.

And like I said, some of the most respected members at Hairsite said they used a solid dose when they did that study.

And the fact that you're saying that their future studies will "more than likely" get better results is all I need to read to know that you believe what you want to believe. Why don't you just declare that Replicel will give complete reversal of hair loss since that's what you want to believe? Oh wait, you are kind of saying that Replicel will give complete reversal of hair loss.

I guess I touched a nerve lol

You're not even listening to what I'm saying at all, I'm clearly stating phase I rarely gets maximum efficacy because they're not trying for it yet.

and I've never stated this is a 100% cure, I've never said it can regrow a head of hair don't put words in my mouth. All I've said is it can immunize hairs, grow some new hair and strengthen and thicken existing hair. Which is what replicel has stated themselves

 

[Breyfogle]

That link says they're testing for dosage in phase 1, and finding the proper dose includes finding the lowest dose that achieves efficacy. You're just taking advantage of the fact they didn't explicitly use the word "efficacy" but of course when they look for the lowest possible dose they can use they mean they are looking for the lowest possible dose with efficacy. What do you think they mean when they say they are testing for the right dosage? Do you think they mean they are trying to find the lowest dose that builds the most houses or find the lowest dose that surfs the internet the best? When they say they are trying to find the correct dose they mean they are trying to find the lowest dose WITH EFFICACY.

And like I said, some of the most respected members at Hairsite said they used a solid dose when they did that study.

And the fact that you're saying that their future studies will "more than likely" get better results is all I need to read to know that you believe what you want to believe. Why don't you just declare that Replicel will give complete reversal of hair loss since that's what you want to believe? Oh wait, you are kind of saying that Replicel will give complete reversal of hair loss.

Wow. What a psycho.
We all know phase 1 studies are low dose safety studies. That's the whole point.
The FDA page is implying that all data eventually is useful for dosing modalities, even the meager phase 1 safety bit.

I'll give you a pass because you're losing your hair and that makes guys fkn crazy.
Send me some more of those awesome hairsite links tho bro. That place looks legit.
For me to piss on.

 

[distracted]

Nameless is this forum's resident conspiracy theorist nut-job. I'd take everything he says with 20 grains of salt.

 

[Torin]

Hair Site does seem like a good source of information.

 

[macbeth81]

"Where did you read it was a substantial dose?"

I heard from Replicel CEO, Mr. David Hall himself. He stated it was a significant dose, and that they were dosing down. That was in an interview made over four years ago after they released their Phase I/IIA results.

HairSite used to be the best boards years ago in terms of knowledgeable posters, but it is basically the roger_that, jarjarbinx, and cal forum now...

 

[nameless]

Nameless is this forum's resident conspiracy theorist nut-job. I'd take everything he says with 20 grains of salt.

Well then you give more credence to the stuff I say than I give to the stuff you say since I completely reject 100% of what you post.

 

[hellouser]

I heard from Replicel CEO, Mr. David Hall himself. He stated it was a significant dose, and that they were dosing down. That was in an interview made over four years ago after they released their Phase I/IIA results.

HairSite used to be the best boards years ago in terms of knowledgeable posters, but it is basically the roger_that, jarjarbinx, and cal forum now...

I spoke with Dr. Hoffmann and he said the Phase I dosing was too much.

That ends that debate.

 

[nameless]

I spoke with Dr. Hoffmann and he said the Phase I dosing was too much.

That ends that debate.

It should end that debate, but don't bother trying to tell that to the unicorn owners.

Now I hope I turn out to be wrong but I'm not real hopeful about Replicel.

There is still the possibility that they've tweaked the core technology to improve it. I certainly hope so.

 

[nameless]

Wow. What a psycho.
We all know phase 1 studies are low dose safety studies. That's the whole point.
The FDA page is implying that all data eventually is useful for dosing modalities, even the meager phase 1 safety bit.

I'll give you a pass because you're losing your hair and that makes guys fkn crazy.
Send me some more of those awesome hairsite links tho bro. That place looks legit.
For me to piss on.

No we do not ALL know that phase 1 studies are "low dose safety studies". WTF does that even mean if you don't also include efficacy into the equation?

Are you saying they are trying to ONLY find the lowest dose that is safe? If that's what you're saying then right here and now I can state the absolute lowest safe dose of ALL medicines. Drum roll please...the lowest safe dose for ALL medicines is ZERO. The best way not to risk toxicity or unwanted side effects from medicine is to give the patients ZERO.

But they do give the test subjects medicines. So if they just want to find out the least amount that is safe why give them any? The safest amount to give test subject is none.

IS IT PERHAPS BECAUSE THEY ARE ACTUALLY TRYING TO DETERMINE THE LOWEST DOSE THAT ALSO PRODUCES A DESIRED THERAPEUTIC EFFECT?

Of course.

 

[Blackber]

The people who say are saying it won't work are just as uninformed as those who say it will work. We have to wait and see.

Samumed showed greater efficacy with lower dosing. You never know what can happen, that's the point of doing all these clinical trials

 

[Joxy]

I spoke with Dr. Hoffmann and he said the Phase I dosing was too much.

That ends that debate.

More dosing doesn’t mean better results, lol!

Drink 10 diazepam instead 1 and you will die.

 

[hellouser]

The people who say are saying it won't work are just as uninformed as those who say it will work. We have to wait and see.

Samumed showed greater efficacy with lower dosing. You never know what can happen, that's the point of doing all these clinical trials

Verdict can be made once Phase II trial results are in. Until then, everyone is wrong.

 

[Blackber]

Verdict can be made once Phase II trial results are in. Until then, everyone is wrong.

Agreed. Have a voice of reason people.

 

[nameless]

The people who say are saying it won't work are just as uninformed as those who say it will work. We have to wait and see.

Samumed showed greater efficacy with lower dosing. You never know what can happen, that's the point of doing all these clinical trials

So then are you saying that Samumed was trying to find the lowest dose that would be effective?