Tricomin clinical trial?
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youngbaldie
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http://www.tricomin.com/pages/why.html
Here are pics from their website I just did a search on google.
Here are pics from their website I just did a search on google.
youngbaldie
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ProCyte Corporation (Nasdaq-NNM: PRCY) today said that it obtained statistically significant results in an initial study of its hair growth compound, PC1358, in a group of men, ranging in age from 18 to 40 years old, with male pattern hair loss. The early-stage Phase II clinical study of the companys investigational compound, tradenamed Tricomin(R) solution, enrolled 36 men with early to mid-stage androgenetic alopecia -- or male pattern hair loss. Thirty-three of the participants were evaluable in the study, in which they were randomly assigned to either one of two dose groups or the vehicle formulation. Study participants topically applied the assigned treatment twice a day for 24 weeks.
The studys prospectively designed endpoints included determination of the effect of 1.25% and 2.5% doses of PC1358 versus vehicle on total hair count and hair weight measured in a one square centimeter treatment area located on the top of the head. An additional endpoint included a general cosmetic assessment of the treated area. Treatment with 2.5% PC1358 resulted in a statistically significant increase in the total hair count when compared to vehicle treatment over the course of the study. Appreciable increases in total hair weight were not found over the treatment phase of the study.
In the general cosmetic assessment, all participants treated with the high dose compound believed they were either growing more hair or staying the same, while almost half of the vehicle-treated participants believed they were losing more hair over the course of the study. The Phase II single center, double-blinded study also provided a further safety assessment of the compound. There were no serious drug-related adverse events reported in the study.
PC1358 is a copper peptide compound. While the specific mechanism of action of the compound is not known, in vivo and in vitro studies have shown this class of compounds to be pharmacologically active in stimulating and protecting hair follicles. Additional studies have shown that PC1358 stimulates the synthesis of major extracellular matrix components involved in hair follicle regulation.
ProCyte Corporation is a development stage healthcare company that is developing a class of proprietary copper peptide compounds for wound care, tissue repair and related applications.
SOURCE ProCyte Corporation
CONTACT: Karen L. Hedine, Vice President of ProCyte
The studys prospectively designed endpoints included determination of the effect of 1.25% and 2.5% doses of PC1358 versus vehicle on total hair count and hair weight measured in a one square centimeter treatment area located on the top of the head. An additional endpoint included a general cosmetic assessment of the treated area. Treatment with 2.5% PC1358 resulted in a statistically significant increase in the total hair count when compared to vehicle treatment over the course of the study. Appreciable increases in total hair weight were not found over the treatment phase of the study.
In the general cosmetic assessment, all participants treated with the high dose compound believed they were either growing more hair or staying the same, while almost half of the vehicle-treated participants believed they were losing more hair over the course of the study. The Phase II single center, double-blinded study also provided a further safety assessment of the compound. There were no serious drug-related adverse events reported in the study.
PC1358 is a copper peptide compound. While the specific mechanism of action of the compound is not known, in vivo and in vitro studies have shown this class of compounds to be pharmacologically active in stimulating and protecting hair follicles. Additional studies have shown that PC1358 stimulates the synthesis of major extracellular matrix components involved in hair follicle regulation.
ProCyte Corporation is a development stage healthcare company that is developing a class of proprietary copper peptide compounds for wound care, tissue repair and related applications.
SOURCE ProCyte Corporation
CONTACT: Karen L. Hedine, Vice President of ProCyte
Beethoven
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Thank you very much youngbaldie!
This raises some additional questions, I hope you or someone else know the answers:
1. When this was published? (if it was published 10 years ago and nothing changed toward fda approval for hairloss then maybe it's not so good...)
2. Is it from some press release or did they eventually published a paper in peer reviewed journal?
3. I remember reading that tricomin contains less than 2.5% is it true and why?
This raises some additional questions, I hope you or someone else know the answers:
1. When this was published? (if it was published 10 years ago and nothing changed toward fda approval for hairloss then maybe it's not so good...)
2. Is it from some press release or did they eventually published a paper in peer reviewed journal?
3. I remember reading that tricomin contains less than 2.5% is it true and why?
youngbaldie
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1) I believe it was published in 97. I believe the company chose not to go into phase III trials because of the cost. Although tricomin holds promise, it probably peforms along the lines of 2% Rogaine at best. It tends to possibly promote scalp health rather than significant hair growth. Tricomin could be a very good option for those who have had no success from Rogaine or who dropped it due to systematic side effects. Copper peptides apparently work from a completely different angle than minoxidil. So really, tricomin is a viable alternative, and that is a great thing, but it probably wasnt so revolutionary to be worth the time, effort, or cost to push it through phase III trials. It is very unlikely that tricomin would ever out perform the other two FDA approved hair loss treatments.
2) I believe this was from a press release from Reuters.
Copyright 1997, Reuters News Service KIRKLAND, Wash., April 4 /PRNewswire/
Honestly, I am not sure if this study was peer reviewed or published in any medical journals. More knowledgable posters like Bryan, Michael Barry, or CCS might know the answer to that.
3) Yes, if I remember correctly, the currently formula of tricomin that is commercially sold from the company contains less than 2.5%. I am not exactly sure why this is, although I think the company has stated that although it contains less, the current product has a better delivery capability than the one tested in their trials. Bryan or Michael Barry would probably know more about this, you could PM them and they might know the answer.
2) I believe this was from a press release from Reuters.
Copyright 1997, Reuters News Service KIRKLAND, Wash., April 4 /PRNewswire/
Honestly, I am not sure if this study was peer reviewed or published in any medical journals. More knowledgable posters like Bryan, Michael Barry, or CCS might know the answer to that.
3) Yes, if I remember correctly, the currently formula of tricomin that is commercially sold from the company contains less than 2.5%. I am not exactly sure why this is, although I think the company has stated that although it contains less, the current product has a better delivery capability than the one tested in their trials. Bryan or Michael Barry would probably know more about this, you could PM them and they might know the answer.
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Youngbaldie, everything you said is right on the money. Let me add my own two cents' worth:
1) ProCyte couldn't POSSIBLY have coughed-up the $$$ required to do a Phase III trial for FDA approval. It would have bankrupted them! So, all they could do was release it as an OTC product, without any hair-growth claims.
2) Their Tricomin trial has almost certainly never been been published in any medical journal, although I've posted in the past about the three chapters written by Ron Trachy (of ProCyte) and colleagues in the book Dermatologic Research Techniques. They described in detail other hairloss trials with various copper peptides, in both humans and animals.
3) The concentration of the copper-peptide in the commercial version of Tricomin is indeed less than what was used in the clinical trial, for the simple reason that it's expensive to produce. According to Trachy of ProCyte (I personally talked to him about it at length on the telephone), they made up for that by enhancing the effectiveness of the vehicle. They claim that the effectiveness of the commercial version is somewhere between the effectiveness of the 1.25% and 2.5% versions used in the trial, but "closer to the 2.5%".
1) ProCyte couldn't POSSIBLY have coughed-up the $$$ required to do a Phase III trial for FDA approval. It would have bankrupted them! So, all they could do was release it as an OTC product, without any hair-growth claims.
2) Their Tricomin trial has almost certainly never been been published in any medical journal, although I've posted in the past about the three chapters written by Ron Trachy (of ProCyte) and colleagues in the book Dermatologic Research Techniques. They described in detail other hairloss trials with various copper peptides, in both humans and animals.
3) The concentration of the copper-peptide in the commercial version of Tricomin is indeed less than what was used in the clinical trial, for the simple reason that it's expensive to produce. According to Trachy of ProCyte (I personally talked to him about it at length on the telephone), they made up for that by enhancing the effectiveness of the vehicle. They claim that the effectiveness of the commercial version is somewhere between the effectiveness of the 1.25% and 2.5% versions used in the trial, but "closer to the 2.5%".
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Here's an alt.baldspot post of mine from 5 years ago in which I discuss the copper-peptide trials in that book I mentioned previously:
On Tue, 09 Jul 2002 02:00:16 GMT, honkguy <honk...@hotmail.com> wrote:
>> >BTW, show me one shred of clinical evidence that SODs grow hair on male pattern baldness
>> >sufferers. Don't pull out the "clinical trials" from ProCyte, either, because
>> >I believe those results about as much as I believe Springhair Tonic works.
>> Why do you feel that way, Mitch? I've previously cited three studies
>> on SODs that were published in a medical journal;
>For male pattern baldness? Could you posts the references if you get a chance?
Oops... I goofed. They weren't published in a medical journal, they were published in the book "Dermatologic Research Techniques", CRC Press, 1996.
They are three consecutive chapters in the book:
Chapter 16: "Phototrichogram Analysis of Hair Follicle Stimulation: A Pilot Clinical Study with a Peptide-Copper Complex" Ronald E. Trachy, Leonard M. Patt, Gordon M. Duncan, and Bernard Kalis. This was done on *human* subjects with male pattern baldness. Both total and anagen hair density increased significantly (anagen hair: +39%) with the larger topical dose of copper-peptide (glycyl-histidine-lysine-valine-phenyalanine-valine), especially when compared to total and anagen hair density LOSSES in the placebo-treated group.
Chapter 17: "Quantitative Assessment of Peptide-Copper Complex-Induced Hair Follicle Stimulation Using the Fuzzy Rat" Ronald E. Trachy, Hideo Uno, Shelley Packard, and Leonard M. Patt. This was done on rats. Copper peptides significantly stimulated hair growth, compared to vehicle.
Chapter 18: "Evaluation of Telogen Hair Follicle Stimulation Using an In Vivo Model: Results with peptide-Copper Complexes" Ronald E. Trachy, Erika D. Timpe, Irene Dunwiddie, and Leonard M. Patt. This was on mice. Copper peptides significantly stimulated hair growth in mice, compared to vehicle; it also exceeded the growth induced by 2% topical minoxidil, which was also tested.
On Tue, 09 Jul 2002 02:00:16 GMT, honkguy <honk...@hotmail.com> wrote:
>> >BTW, show me one shred of clinical evidence that SODs grow hair on male pattern baldness
>> >sufferers. Don't pull out the "clinical trials" from ProCyte, either, because
>> >I believe those results about as much as I believe Springhair Tonic works.
>> Why do you feel that way, Mitch? I've previously cited three studies
>> on SODs that were published in a medical journal;
>For male pattern baldness? Could you posts the references if you get a chance?
Oops... I goofed. They weren't published in a medical journal, they were published in the book "Dermatologic Research Techniques", CRC Press, 1996.
They are three consecutive chapters in the book:
Chapter 16: "Phototrichogram Analysis of Hair Follicle Stimulation: A Pilot Clinical Study with a Peptide-Copper Complex" Ronald E. Trachy, Leonard M. Patt, Gordon M. Duncan, and Bernard Kalis. This was done on *human* subjects with male pattern baldness. Both total and anagen hair density increased significantly (anagen hair: +39%) with the larger topical dose of copper-peptide (glycyl-histidine-lysine-valine-phenyalanine-valine), especially when compared to total and anagen hair density LOSSES in the placebo-treated group.
Chapter 17: "Quantitative Assessment of Peptide-Copper Complex-Induced Hair Follicle Stimulation Using the Fuzzy Rat" Ronald E. Trachy, Hideo Uno, Shelley Packard, and Leonard M. Patt. This was done on rats. Copper peptides significantly stimulated hair growth, compared to vehicle.
Chapter 18: "Evaluation of Telogen Hair Follicle Stimulation Using an In Vivo Model: Results with peptide-Copper Complexes" Ronald E. Trachy, Erika D. Timpe, Irene Dunwiddie, and Leonard M. Patt. This was on mice. Copper peptides significantly stimulated hair growth in mice, compared to vehicle; it also exceeded the growth induced by 2% topical minoxidil, which was also tested.
youngbaldie
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Very informative as always. Thanks for that Bryan.
youngbaldie
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Beethoven, in response to your previous question about folligen, honestly, I have never tried any of these products. But I have heard that folligen tends to burn the scalp, probably due to some other chemical in the product, maybe too much alcohol, not sure. If you have male pattern baldness, this is the last thing you need. Personally, I would stay away from folligen.
I have also heard that tricomin usually has a more soothing effect on the scalp.
Prox-N seems like a very solid product too. I would consider using that, tricomin, or possibly both.
I have also heard that tricomin usually has a more soothing effect on the scalp.
Prox-N seems like a very solid product too. I would consider using that, tricomin, or possibly both.