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?

Product review: CLn Bodywash, the "bleach bath in a can"

A PR firm retained by TopMD Skin Care, a Dallas-based startup company, approached me about reviewing the company's first product: CLn Bodywash, which has been described as a bleach bath in a can.

CLn Bodywash, the company says, was designed to treat bacterial infections of the skin, such as acne and the staph infections that often accompany eczema. The product comes in a small can like shaving cream--when you squeeze it out, it's a gel that you're supposed to rub into a lather and apply in the shower. It contains sodium hypochlorite (bleach) plus some unspecified surfactants, which essentially means detergent.

The idea of bleach baths makes sense to me. That's why I took them up on their offer.

They sent me two bottles in the mail. I like getting free stuff, so this was cool. The thing is, when you get something designed to treat a staph infection, you have to sit around and wait until you get one.

But I have eczema, so that didn't take long. This was the first time in my life I welcomed an outbreak of folliculitis. (Sorry, TopMD, I know you wanted me to test this on my three-year-old daughter, but that ain't gonna happen!)

CLn Bodywash foams up to a less-exciting degree than shaving foam. For me, it was a little bit stringy, like mucus, at first. But you can get it to lather. Then you leave the lather on for 1-2 minutes and rinse.

I used it on some mild folliculitis which appeared first on my left leg. Then, a couple days later, I got it on my right leg too. My first instinct was to use my right leg as an untreated control of sorts. But I hate folliculitis and want it to go away, so I used CLn on both legs.

And my folliculitis went away within a few days. It has not yet returned.

Was this because of CLn? Maybe. In the past, my folliculitis has always gone away. What goes up usually comes down.

On the plus side: CLn didn't make things worse; it didn't dry my skin out unduly; and it didn't smell all perfumy, as so many skin products do.

The obvious place to look for "proof" of whether CLn works is a clinical trial. TopMD claims that CLn has been subject to "extensive clinical testing." I found no evidence of this on the web, and asked the PR firm to send me the link. They kindly sent me a poster that had been presented earlier this year at a conference. The poster describes how the authors tested CLn on 11 subjects (all kids--this is clearly meant for kids) and appears to show that their skin infections largely cleared up.

The thing is--unless I am reading this wrong--the authors were about as scientific as I was. There is no control group, which is one of the most basic requirements for a clinical trial. There is nothing to compare the results to.

The PR rep tells me that there is another clinical trial of CLn just getting started in Houston. [updated 10/30/12]

Until the results of this presumably larger and more rigorous trial come out, I hesitate to recommend CLn Bodywash. I like the idea behind it, but I am not convinced it is any better than a decent soap.