TAKEAWAY FROM WCHR 2013 Edinburgh, UK @ Dr. NIGAM

[MrBlonde]

rdawg,
Doctors can prescribe off label use of topical finasteride since it is approved by FDA for oral use..
Like doctors prescribe lattise(a product of allergan) off label as it has been approved by FDA,USA for growing eyelashes.
Silicion fillers have been cleared by FDA for opthalmic use,and doctors in USA are using it for permanent fillers for face through microdroplet technique.
In INDIA,doctors can compound and dispense a new formulation,provided every ingredient has an FDA approval and bought from FDA registered supplier.But cannot keep this formulation in the pharmacy for general public unless cleared by FDA for it's claims.
That means ,i can compound and dispense to my patients from my clinic or by courier once i find the right solution and vehicle of topical finasteride.
Although this has to be for use of individual patient and not for sale in the market..
If a company launches this product as a drug than minimum it has to do,is prove it's efficacy with trials before FDA allows it's claim...

So you will do your own testing to find the right solution? We are talking months of testing and patient results then before you send out your own topical Fin?

How quickly do you think you can have batches ready to send?

[Arashi]

rdawg,
If a company launches this product as a drug than minimum it has to do,is prove it's efficacy with trials before FDA allows it's claim...

Yup. Minimum is a phase III trial to prove efficacy. So probably a 2 year timeframe before we'll see it on the market.

[drnigams]

Blonde, my major focus of work at present is donor doubling and injections of growth factors,stemcells,and dp cultured cells..whatever time will be left ..i will work on thsi..but any guy into phd on skin permeation will be a better bet to prepare than me..i will also be discussing with experts in skin permeation,the swiss company and also annika voidt from germany ,who's research work is into targetted drug delivery... to prepare the formulation.

So you will do your own testing to find the right solution? We are talking months of testing and patient results then before you send out your own topical Fin?

How quickly do you think you can have batches ready to send?

[drnigams]

Arashi,did you have a look at three studies i posted at hs proving our hypothesis of donor doubling...wherein lower follicle if amputated can regenerate it's own dermal papilla...infact there was a paper on unlimited follicle hair transplant at WCHR...these findings confirm til HM comes doubling is the best solution...

Yup. Minimum is a phase III trial to prove efficacy. So probably a 2 year timeframe before we'll see it on the market.

[rdawg]

Yup. Minimum is a phase III trial to prove efficacy. So probably a 2 year timeframe before we'll see it on the market.

essentially for on label yes, but off label we can get this stuff much sooner than that.

that's still not that far, but i'm not sure I got an answer to my other question, would the efficacy be better(at least in theory) than regular oral fin since it's more localised to the hair? or would it essentially have the same effect?

[hairy]

Legend!!! Dr. Nigam, best wishes this week. Hope you can collaborate with Dr. Jahoda and get some of these people to join you on an advisory basis.

[clandestine]

Legend!!! Dr. Nigam, best wishes this week. Hope you can collaborate with Dr. Jahoda and get some of these people to join you on an advisory basis.

Strong bump. Stop that.

[Kalio]

So whats the deal with this topical Finasteride I am reading about in this thread? Will it have no side-effects as opposed to the oral version of Finasteride?