Thursday, May 23, 2013

TopMD conducts clinical trial of CLn Bodywash for marketing purposes

CLn Bodywash, the “bleach bath in a can,” sounds like a product that we all need—a quick and easy way to cleanse your skin of Staphylococcus aureus and other nasty bacteria associated with eczema. But the marketing campaign arranged by CLn’s maker, Dallas-based TopMD, could be better.

For a start, they could arrange a decent clinical trial.

CLn must be classified as a cosmetic and not a medical product, because the FDA didn’t require tests before CLn hit the stores.

You would think the usual way to proceed with a medical product would be:

1)    clinical trial to prove safe and effective
2)    manufacturing and marketing

But TopMD scientists recently published the results of a clinical trial for CLn in the journal Pediatric Dermatology, about nine months after I first heard the product was for sale.

Of course dilute bleach baths are a known household treatment to manage skin bacteria. CLn is a portable bleach bath and isn't going to be any more hazardous than what thousands of people are already doing in their bathtubs. But is it any better? Is it worth paying money for?

I think that some marketing analyst decided that doctors around the US were reluctant to buy or recommend CLn because it hadn’t undergone a clinical trial. Now it has—with the shiny label “peer-reviewed,” although the journal it was published in is low-impact, and the “peer” who deemed the study worthy of publication could well have been a single graduate student.

The study might possibly qualify as a “phase 0” trial. It’s conducted on 18 subjects all of whom are given the product. There’s no control group that receives a placebo.

This is a problem, because both the doctors conducting the trial and the patients both want the product to work. So the reported results are bound to look better than they really are. Scientifically, this study is far from the final word on whether CLn is truly effective.

The way to avoid this problem is to have a double-blind randomized control trial where, at the very least, half of the patients get CLn and half get something that looks like it but isn’t, and nobody knows which is which until the results have been recorded.

For an example of how this might be done, at least in a way that looks good from a marketing perspective, you can see that the makers of DermaSilk clothing appear to get it right in their studies, the most recent of which was published online this week.

That the recent CLn study was motivated by marketing is clear from one of its measures. Participants were asked “Would you recommend CLn to a friend?” This is not a data point you see in too many scientific papers.

The company’s press release quotes UC San Diego’s Dr. Larry Eichenfield, chief of pediatric and adolescent dermatology at Children's Hospital, San Diego—a world leader in the field. Eichenfield says “I am excited to read the study by Dr. Ryan et al showing the benefits of TopMD's sodium hypochlorite-based body wash.”

The release doesn’t mention that Eichenfield sits on TopMD’s medical board.

I like the idea of CLn, and I think it’s probably a valuable product. I’m happy they sent me a free bottle to review back in October, and I’m keeping it in case I need it. But I wish they could present some more convincing evidence that it works. Are they afraid that it doesn’t? If not, why not use a control group in the study?

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