hair mchair said:
I'm not convinced the lasercomb is a complete scam. I am very skeptical though, especially since we STILL have not heard anything about the lasercomb getting FDA approval for hairloss. We've been waiting around for this for what seems like forever. It's also pretty damn expensive. Costwise, the only advantage is has over other treatments is that it is a one-time cost.
On their webpage they where talking about the status of the trials.
I think that they said that the FDA wanted additional trials because they didnt have a controlled placegroup.
They said that they didnt use one because of the difficulty to create a placebo lazercomb.
This is from their site::
Placebos …..controls…. urgh…..
This has been the most agonizing issue of my last few years.
It is our premise that for a hair growth study the best mode for a control is the ‘Base Line’ hair count. The use of a blinded control was considered for our first clinical study but our factors of the decision to use the Base Line were as follows:
-Androgenetic alopecia is well documented and is known to be regressive. Additional data on hair loss would not add to our statistical analysis. We however used 11% increase in hair count to be considered regrowth which takes into account the placebo effect of Propecia/Minoxidil studies and any changes in waxing and weaning of the hair growth cycles.
-We further considered the precedence of the laser hair removal clinical trials in which used the base line hair count as the control.
-Most importantly we fell it was unethical to place tattoo marks in someone scalp with thinning hair and then closely trim the hair 5 times to perform hair counts. We feel that tattooing and trimming may lead to further hair thinning for that individual.
- The only viable way of including a blind control is to issue a LaserComb without a laser. Users were instructed to read the user manual and watch the video which contains images of the laser light. We feel a control group would not be blind as laser light is visible, and there would be a high probability of noncompliance.
Anyway during the design of our first trial we received a memo from the FDA accepting the base line as the control. However in the final panel review the FDA highlighted the lack of a placebo sham controlled study as one of their reasons for not clearing our device on this round. In case you’re interested some of the other items that were listed as our trial design deficiencies are that we did not diagnosis the etiology of the individuals hair loss and we did not correctly factor in the drop out rate in the statistical analysis.
I once again comment that our clinical data was statistically significant and we felt the strength of the data should have justified clearance. But we are not in a position to question the FDA we only want to provide the necessary material and clinical data for ultimate clearance.
So we are currently back to trial design phase and have our new protocol ready to submit to the FDA. This time we are covering all our bases (I hope) and have developed a sham device as the control.
Regards,
David Michaels