Winlevi ( Cb 03 01 ) For Acne, Fda Approval

[Dalcounter]

Cassiopea's CB was dissolved in a standard PG+ethanol+distilled water solution if I'm not wrong. I'm using it with Trichosol that has water and I don't have any problem with that.

You didn't respond to my former question. You took those number from a Spanish user, but I'm wondering why you call him Kevin.

What u consider the best regimen for someone with strong familiarity with hiar loss ( dad nw3.5 maternal nw7 uncles nw6 paternal grand nw2) .I take 1mg fina daily but im sure isnt enough.

 

[Canuto]

Hi Canuto, slightly off-topic, for a person who's on TRT, would you recommend CB or RU? I have a choice between the two and not sure which one to use. Have read the RU is stronger, but the sides may be worse. Any advice?

CB or CPA topical. I use both combined.

 

[Canuto]

What u consider the best regimen for someone with strong familiarity with hiar loss ( dad nw3.5 maternal nw7 uncles nw6 paternal grand nw2) .I take 1mg fina daily but im sure isnt enough.

There are several things you can add topically: estrogens, topical AA, prostaglandins analogues, progesterone, growth agonists, wnt pathway agonists and ancillaries. It depends on how much you want to invest in terms of money and time and if you're willing to do blood tests to monitor you're not harming yourself.

 

[Badbald]

Has anyone tried contacting any pharmacies about getting this now that its FDA approved we should be able to get this made up right now..

 

[Mr White]

Breezula is the only treatment that I'm interested in. I couldn't care less about the Japanese doctor, he can stick the treatment up his a**.

 

[Dimitri001]

Forgive me for quoting my own post, but it seems there's more interest in this HPA business now then when this was posted and there's been some discussion of it in the interim, so I'm hoping someone might have some thoughts on this, in particular I'm curious about what you, @Canuto, think about this, since you seem to be knowledgeable on this.

This HPA thing really is strange. You got this tiny study where of about 40 subjects, 3 get it, but then you have this:

The 3 Phase II studies, n=477, revealed minimal systemic absorption; the active ingredient works locally within hair follicle. Subjects did not show clinical evidence of adrenal suppression under maximal use conditions. (this is also Winlevi, not Breezula)

How the hell do you account for this?

There's a further issue with CB, which is that the story about it metabolizing quickly and being entirely absent from plasma isn't true.

This is from a paper summarizing phase I and II studies:

Phase I study: Clascoterone reached the blood stream after a single dose and repeated BID
application to the alopecic areas. Quantifiable plasma clascoterone concentrations
were found in all treated subjects, from 4 hours after the first application and
increasing during the treatment period. Day 28 pre-dose clascoterone concentration
was similar to the 12-hour postdose concentration—indicating steady state.

Now, they don't give what the concentration is and perhaps it's something negligible and irrelevant, but... I haven't been able to find the phase I study paper to find that info.

To this I'll add that my understanding is that the way you test for HPA suppression is by measuring cortisol levels, if that's true, here's what they said in the Breezula dosing study:

Since the chemical structure of Clascoterone is similar to that of a steroid while its function is not, cortisol levels were tested in a sub-group of patients to verify that Clascoterone is free from systemic steroid activity. The mean absolute changes of cortisol values throughout the study were similar among groups, proving that Clascoterone has no systemic effect on cortisol.

So, that's 300+ ppl taking CB in concentrations higher than winlevi and getting no HPA suppression. Furthermore, there have been other winlevi studies where they specifically studied sides and no mention of HPA in those

How do you account for this?

 

[Dimitri001]

CB has to be applied twice a day. You can get by with 1ml to save money, but 2 is better. That's $7.50 per day buying from Kane. There have been a couple recent studies showing systemic absorption, including the safety data from the acne trial. For whatever reason, it doesn't seem to really be metabolized as quickly as we were told when it hits the bloodstream. If estriol goes systemic it's probably less likely to cause sides than other AAs if you keep the dose around 10mg/day. Topical dutasteride once every one to two weeks might be the best option for people who are highly sensitive to AA sides. CB might be ok too if you can swing the $225-$450/month from Kane. There's only one way to find out.

Which studies are you referring to here? I think this was found in the phase I Breezula trial, are you talking about that or something else?

 

[Canuto]

Forgive me for quoting my own post, but it seems there's more interest in this HPA business now then when this was posted and there's been some discussion of it in the interim, so I'm hoping someone might have some thoughts on this, in particular I'm curious about what you, @Canuto, think about this, since you seem to be knowledgeable on this.


To this I'll add that my understanding is that the way you test for HPA suppression is by measuring cortisol levels, if that's true, here's what they said in the Breezula dosing study:

Since the chemical structure of Clascoterone is similar to that of a steroid while its function is not, cortisol levels were tested in a sub-group of patients to verify that Clascoterone is free from systemic steroid activity. The mean absolute changes of cortisol values throughout the study were similar among groups, proving that Clascoterone has no systemic effect on cortisol.

So, that's 300+ ppl taking CB in concentrations higher than winlevi and getting no HPA suppression. Furthermore, there have been other winlevi studies where they specifically studied sides and no mention of HPA in those

How do you account for this?

They will need to clarify that in phase III obviously.
To be an HPA suppressant, it should work the same way as as Dexamethasone when used to diagnose the Cushing's syndrome. It's a glucocorticoid that binds to the corticosteroids receptors in the hypothalamus, which in turn signal the pituitary to stop producing ACTH. So no ACTH means no cortisol, which will mean adrenals suppression.
If clascoterone is able to raise the levels of cortexolone in blood stream considerably, then there's an obvious risk for adrenals shutdown, which is probably even worse than hypogonadism.
People get in the ER for Addison's disease, which is the inability of adrenals to secrete corticosteroids and DHEA.

 

[Equal Rights]

They will need to clarify that in phase III obviously.
To be an HPA suppressant, it should work the same way as as Dexamethasone when used to diagnose the Cushing's syndrome. It's a glucocorticoid that binds to the corticosteroids receptors in the hypothalamus, which in turn signal the pituitary to stop producing ACTH. So no ACTH means no cortisol, which will mean adrenals suppression.
If clascoterone is able to raise the levels of cortexolone in blood stream considerably, then there's an obvious risk for adrenals shutdown, which is probably even worse than hypogonadism.
People get in the ER for Addison's disease, which is the inability of adrenals to secrete corticosteroids and DHEA.

This has officially become the most confusing paragraph I have read on this forum.

 

[Canuto]

This has officially become the most confusing paragraph I have read on this forum.

Ha!
To make it simple, when you introduce an exogenous hormone in the body and your body senses it (through the receptors) it will shutdown the correspondent pathway.
So in the case of CB0301, if cortexolone (a corticosteroid and metabolite of clascoterone) gets too high in the bloodstream and reaches the corticosteroids receptors in the hypothalamus, the latter will signal the pituitary to stop producing ACTH. No ACTH means no cortisol production from the adrenals, hence HPA shutdown.
That's I think the mechanism involved in the adrenals shutdown reported with Winlevi. For the rest, we need to wait phase III and even better phase IV when they will report all the side effects on a wider sample. If they manage to get it approved from the FDA obviously.

 

[LouisSarkozy]

Ha!
To make it simple, when you introduce an exogenous hormone in the body and your body senses it (through the receptors) it will shutdown the correspondent pathway.
So in the case of CB0301, if cortexolone (a corticosteroid and metabolite of clascoterone) gets too high in the bloodstream and reaches the corticosteroids receptors in the hypothalamus, the latter will signal the pituitary to stop producing ACTH. No ACTH means no cortisol production from the adrenals, hence HPA shutdown.
That's I think the mechanism involved in the adrenals shutdown reported with Winlevi. For the rest, we need to wait phase III and even better phase IV when they will report all the side effects on a wider sample. If they manage to get it approved from the FDA obviously.

canuto you're a hero man . with your knowledge and from your point of view for someone who is'nt on trt and who can't afford to wait for breezula phase 3 results cause i'm loosing ground too fast is it safer to add a low dose of cb or a low dose of ru right now? ( btw thanks for your advices i receive the products from parati and the vehicle are top tier especially the trichocream minus the smell)

 

[Canuto]

canuto you're a hero man . with your knowledge and from your point of view for someone who is'nt on trt and who can't afford to wait for breezula phase 3 results cause i'm loosing ground too fast is it safer to add a low dose of cb or a low dose of ru right now? ( btw thanks for your advices i receive the products from parati and the vehicle are top tier especially the trichocream minus the smell)

Try CB, but get a baseline ACTH, cortisol and DHEA-S levels and retest after 2 weeks to see if they got affected.

 

[HyperReal]

Try CB, but get a baseline ACTH, cortisol and DHEA-S levels and retest after 2 weeks to see if they got affected.

Thank you Canuto for your good advice.

I am considering having a blood test before starting CB. Is there something else to test (DHT and testosterone) ?

 

[Canuto]

Thank you Canuto for your good advice.

I am considering having a blood test before starting CB. Is there something else to test (DHT and testosterone) ?

CB won't affect none of the 2 if it's genuine CB, so, with metabolite being a corticosteroid, the only necessary thing to check is adrenal function. The rest is optional.

 

[LouisSarkozy]

Albany Molecular Research Inc. (AMRI) Named Exclusive API Supplier for Recently Approved Acne Treatment

AMRI has been named as the exclusive supplier of the API in Cassiopea SpA’s recently approved acne treatment, Winlevi® (clascoterone) cream 1%.

www.businesswire.com

just found that winlevi supposed to be available first quarter of 2021 in the us hopefully its the same for europe but the scary part is this https://www.winlevi.com/assets/WINLEVI-clascoterone-cream-prescribing-info-08-2020.pdf

they do mention hpa axis suppression as a side effect of the drug even at 1 % wtf "Hypothalamic-pituitary-adrenal (HPA) axis suppression mayoccur during or after treatment with clascoterone. (5.2)"

they do mention it may be reversible after cessation tho ..

 

[tomJ]

Albany Molecular Research Inc. (AMRI) Named Exclusive API Supplier for Recently Approved Acne Treatment

AMRI has been named as the exclusive supplier of the API in Cassiopea SpA’s recently approved acne treatment, Winlevi® (clascoterone) cream 1%.

www.businesswire.com

just found that winlevi supposed to be available first quarter of 2021 in the us hopefully its the same for europe but the scary part is this https://www.winlevi.com/assets/WINLEVI-clascoterone-cream-prescribing-info-08-2020.pdf

they do mention hpa axis suppression as a side effect of the drug even at 1 % wtf "Hypothalamic-pituitary-adrenal (HPA) axis suppression mayoccur during or after treatment with clascoterone. (5.2)"

they do mention it may be reversible after cessation tho ..

Your late to the party. We have been discussing this for a while...many are bummed by this and fyi it is due out around March 2021.

 

[franzliszt]

thought this might be of relevance

Topical Cyproterone Acetate Treatment in Women With Acne

Objective To evaluate the clinical and hormonal response of topically applied cyproterone acetate, oral cyproterone acetate, and placebo lotion in women with acne.Design Placebo-controlled, randomized study.Setting Patients were recruited from the Institute of Endocrine Cosmetics,...

jamanetwork.com

 

[Dimitri001]

Ha!
To make it simple, when you introduce an exogenous hormone in the body and your body senses it (through the receptors) it will shutdown the correspondent pathway.
So in the case of CB0301, if cortexolone (a corticosteroid and metabolite of clascoterone) gets too high in the bloodstream and reaches the corticosteroids receptors in the hypothalamus, the latter will signal the pituitary to stop producing ACTH. No ACTH means no cortisol production from the adrenals, hence HPA shutdown.
That's I think the mechanism involved in the adrenals shutdown reported with Winlevi. For the rest, we need to wait phase III and even better phase IV when they will report all the side effects on a wider sample. If they manage to get it approved from the FDA obviously.

Sorry to keep badgering you about this, but I'm trying to figure out whether this is something I'd be willing to risk, so I'm trying to get a clear picture of what it means for the patient, practically.

Suppose what you describe were to happen, what are the actual consequences/symptoms of it? What negative health effects would it cause and what would be the consequences of staying on it long term if HPA shutdown were to happen?

thought this might be of relevance

Topical Cyproterone Acetate Treatment in Women With Acne

Objective To evaluate the clinical and hormonal response of topically applied cyproterone acetate, oral cyproterone acetate, and placebo lotion in women with acne.Design Placebo-controlled, randomized study.Setting Patients were recruited from the Institute of Endocrine Cosmetics,...

jamanetwork.com

Hmm... what am I missing, what's the relevance?

 

[franzliszt]

Sorry to keep badgering you about this, but I'm trying to figure out whether this is something I'd be willing to risk, so I'm trying to get a clear picture of what it means for the patient, practically.

Suppose what you describe were to happen, what are the actual consequences/symptoms of it? What negative health effects would it cause and what would be the consequences of staying on it long term if HPA shutdown were to happen?


Hmm... what am I missing, what's the relevance?

Both Cb and cypro are effective at reducing acne as topical anti androgens. The same may be true when using cypro as a topical treatment for hairloss.

 

[LouisSarkozy]

Sorry to keep badgering you about this, but I'm trying to figure out whether this is something I'd be willing to risk, so I'm trying to get a clear picture of what it means for the patient, practically.

Suppose what you describe were to happen, what are the actual consequences/symptoms of it? What negative health effects would it cause and what would be the consequences of staying on it long term if HPA shutdown were to happen?


Hmm... what am I missing, what's the relevance?

would like to know aswell as i got my cb powder on the way but kinda scared to use it because of that.