3 replies to this topic

[paigems]

Hi everyone,

 

If any of you guys have read my post on the hormonal treatments I have tried you would know I have tried almost all of them. Recently I was invited to participate in the clinical trial for CB-03-01 which is a new topical anti- androgen (basically like spiro without the systemic effects). Do you guys think it's a good idea to be in clinical trials for hormonal treatments? I worry that because it's only in phase 2 once the trial is up I won't be able to use it anymore and my skin will go crazy similar to the effect I have when stopping other anti-androgens. Or, do you think it would be best to just wait until it comes to market?

 

 

[michi31]

How exciting! It's about freaking time they come out with a topical anti-androgen. I was just asking my endocrinologist about this and he said there was none. I looked it up, in case others are interested:

 

"Sіnсе wе′re аll wondering whеn іt’s lіkеlу thаt thе product wіll hit thе market, іf іt dοеѕ, I аѕkеd Cosmo Pharmaceuticals myself.

Chief Medical Officer wrote:

CB-03-01іѕ a nеw, patented, anti-androgen fοr topical υѕе whісh acts οnlу οn thе skin, іѕ inactivated іn crossing thе skin, аnd dοеѕ nοt exert systemic activity. Beside іtѕ strong anti-androgenic properties, thе product іѕ аlѕο endowed wіth mild antiinflammatory activity, whісh ѕhουld bе useful іn thе presence οf dermal inflammation аѕ іn thе case οf androgentic alopecia. In a proof οf concept performed іn AGA subjects treated wіth iontophoresis, CB-03-01 1% resulted clinically more effective thаn application οf cyproterone acetate аnd 17-alpha estradiol аnd, аt confocal microscopy, іt ѕhοwеd аlѕο positive effects οn sebaceous glands, vascular аnd connective tissue envelopping thе hair follicle.

On thе basis οf thеѕе encouraging results, additional Phase II аnd Pase III studies аrе рlаnnеd tο file thе product within 2013.

If аll goes according tο thе рlаn, thе studies wіll bе fіnіѕhеd within 2013. I guess 2014 іѕ thе earliest bet. I don’t know hοw long іt usually takes, fοr one drug tο bе approved fοr υѕе іn regions around thе world."

 

I like that it says it doesn't cross the skin - I wonder if it could be used in pregnancy??

 

So anyway, whether you should do it - I do not know. It seems like in all the clinical trials I have read the participants had good - great results. I am certainly not qualified to answer whether there would be any s/e or long-term consequences. Have you researched what happened in phase 1? Can you express your concerns and ask about the risks? How did you get chosen if you don't mind me asking?

Ok I'm confused because it seems they already did clinical trials back in 2009/10.... what is the deal with that?

 

http://www.cosmophar...2009-12-11.aspx

[paigems]

Yes it is very exciting! From what I've read it seems there was no adverse affects from CB-03-01. I think I'm just a little cautious because I have a reaction to just about everything lol. If anyone would have one, it would be me. I guess I'm just very sensitive. I have not met with the people performing the clinical trial yet, and I'm still not sure if I will, but if I do I think you're right that asking them about my concerns would be a good idea. I didn't think of that. However, I may just wait until Phase 3 which could be later this year.

 

And the clinical trials you're seeing for 09/10 were performed in Europe because it is originally a European company. Those clinical trials went well, and showed it to be more affective than retin-a for treating acne so they are repeating the clinical trials over here.

 

http://clinicaltrial...how/NCT01631474

 

There's the clinical trial. If you scroll down to contacts and locations you can see where they are recruiting participants. One location happens to be near me so I emailed them, and they got back to me saying they were interested in having me participate.

[michi31]

I wonder if they could tell you how those people in the Europe trials did aftewards..maybe even put you in touch with some of them so you could see how they are doing now. But yeah I understand if you just want to wait longer...since you would have to come off of it anyway. Keep us posted on what you decide! I think it's really interesting.