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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?
End Eczema

Lilly/Incyte pill beats placebo in mid-stage eczema trial – WHTC

Lilly/Incyte pill beats placebo in mid-stage eczema trial
WHTC
The Phase 2 eczema trial found that after 16 weeks, 61 percent of patients on the highest dose of baricitinib and a topical corticosteroid had at least a 50 percent reduction in symptoms, compared to 37 percent of patients treated with just a steroid

and more »

eczema – Google News

Lilly/Incyte pill beats placebo in mid-stage eczema trial – WHTC


Reuters
Lilly/Incyte pill beats placebo in mid-stage eczema trial
WHTC
The Phase 2 eczema trial found that after 16 weeks, 61 percent of patients on the highest dose of baricitinib and a topical corticosteroid had at least a 50 percent reduction in symptoms, compared to 37 percent of patients treated with just a steroid
Baricitinib improves outcomes in patients with atopic dermatitisHealio
Lilly's baricitinib fails to outshine Sanofi's DupixentBioPharma Dive
Lilly Announces New Safety And Efficacy Data From Phase 2 Study Of BaricitinibMarkets Insider

all 7 news articles »

eczema – Google News

Drug for refractory psoriatic arthritis shows promise in clinical trial

In a pivotal phase-3 clinical trial led by a Stanford University School of Medicine investigator, patients with psoriatic arthritis for whom standard-of-care pharmaceutical treatments have provided…
Eczema / Psoriasis News From Medical News Today

NYC area clinical trial for eczema therapy recruiting participants

A research group at Rockefeller University in New York City seeks participants for a clinical trial of an experimental therapy for atopic dermatitis. See below for details.

Dr. Emma Guttman-Yassky, Dr. Saakshi Khattri and others are exploring whether Stelara (ustekinumab), currently approved in the US for treatment of psoriasis, might benefit patients with moderate to severe AD whose condition has not improved with conventional treatment.

Ustekinumab is a monoclonal antibody to the p40 subunit of the signaling proteins IL-12 and IL-23. It binds to these proteins and prevents them from working. Since IL-12 and IL-23 are involved in the development of certain kinds of T cells, ustekinumab will put a damper on a subset of the T cell arm of the immune system.

I started to speculate about exactly how ustekinumab might work for AD but then I wisely looked at the researchers’ own explanation on clinicaltrials.gov. I was only 25% right, so you’d do well to look at their writeup if you’re interested.

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

Randomized Pilot Study of Ustekinumab for Subjects with Chronic Atopic Dermatitis Who Have Sub-optimal Response to Prior Therapy

This study is currently recruiting participants.
Verified March 2013 by Rockefeller University

Sponsor:
Rockefeller University

Information provided by:
Rockefeller University

ClinicalTrials.gov Identifier: NCT01806662

Purpose
We are carrying out a clinical trial with the drug Stelara (ustekinumab), which is already FDA approved for Psoriasis, in patients with moderate to severe eczema, ages 18 years – 75 years.  In order to be eligible, a patient must have failed at least topical steroids and either light therapy or oral steroids. Patients will have 15 visits over the course of a year at Rockefeller University, which is located on the Upper East Side of New York City. Patients are guaranteed to receive 3 doses of Stelara throughout the study. Patients will also be allowed to use Triamcinolone 0.025% during the course of the study.  If the medication is effective at clearing a patient’s eczema, they will be eligible to receive an extra dose at the completion of the study.  For full participation, patients are compensated $ 600.

Name/Title of the Principal Investigator: Dr. Emma Guttman, MD/PhD

Contact Information:
Saakshi Khattri, MD – Clinical Research Fellow
1230 York Avenue
New York, NY  10065
Business number: 212-327-8354/8333
Fax number: 212-327-8232
Recruitment Office 1-800-782-2737
email: skhattri@rockefeller.edu

For more information, please visit:
http://clinicaltrials.gov/ct2/show/NCT01806662
End Eczema

Independent trial showed No Significant Benefit of Silk Clothing for Eczema kids

An eczema study1 published in April 2017 showed that there was

little evidence of clinical or economic benefit of using silk garments in addition to standard care, compared with standard care alone, in children with moderate to severe eczema.

As always, the team of researchers from the University of Nottingham in the U.K had taken on clinical studies that address questions raised by doctors and patients, with the view of having a direct impact on clinical practice. They had conducted very practical studies like softened water eczema trial and compared the efficacy of a short burst of potent topical corticosteroids versus prolonged period of mild corticosteroids. Their website also maps out the systematic reviews on eczema and list their ongoing studies (also found at the bottom of this post).

For this study, the key points are below:

Nature of study: Parallel-group, randomised, controlled, observer-blind trial

Participants: Children aged 1 to 15 year old with moderate to severe eczema; 300 children were included: 42% girls, 79% white, mean age 5 year old

Randomized groups: Participants were randomised to receive standard eczema care plus silk clothing (100% sericin-free silk garments; DermaSilk or DreamSkin) or standard care alone.

Measurement: At baseline, 2, 4 and 6 months against the Eczema Area and Severity Index (“EASI”)

Outcome: No evidence of a difference between the groups in eczema severity (EASI score) assessed by research nurses

Purpose of the study: Silk clothing is available on prescription (and online) but the randomized controlled trials previously done were for small group of participants. To provide direction for clinical practice as to whether to recommend silk clothing, this study was taken on. Silk garment claimed beneficial for eczema as they are smooth, helped regulate humidity and temperature, reduce scratching damage and have anti-microbial properties. These are important qualities that would benefit eczema to reduce scratching (versus a ‘scratchy’ fabric like wool), keep the skin cool and reduce likelihood of flucuating temperature triggering eczema flareups and reduce bacteria load as eczema skin is prone to staph bacteria colonization. However, from the outcome of this study, it would appear that standard eczema care such as regular emollient use and topical corticosteroids (or topical calcineurin inhibitors) for controlling inflammation would be adequate.

Study by the researchers at the University of Nottingham, UK on Efficacy of Silk Clothing for Eczema Children

Study by the researchers at the University of Nottingham, UK

Practical implication:

In my view, this study would really get parents who are spending a lot of money on silk clothing/ bedding to question if such money needs to be spent. These silk garments are not cheap but parents pay for them due to positive testimonies, anti-inflammatory/ anti-microbial properties of silk and that these clothing are soft, free of dye and will not irritate the skin (interviewed Dermasilk here). However, a lower-cost alternative of cotton may work as well, with standard care for eczema.

My personal take is if you’re seeing benefits for your child with silk clothing and can afford it, there is no reason to stop using the clothing. However, if it hasn’t seemed to make much difference and you feel confident that the eczema therapeutics measures that you use for your child are sufficient, then it makes sense not to spend that money. See this post for the review of various eczema therapeutics and also the review study that Nottingham University had done.

References:

Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial) Thomas KS, Bradshaw LE, Sach TH, Batchelor JM, Lawton S, et al. (2017) Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial). PLOS Medicine 14(4): e1002280. https://doi.org/10.1371/journal.pmed.1002280

Ongoing studies at Centre of Evidence Based Dermatology at Nottingham University:

Bath Additives in the Treatment of Childhood Eczema

Barrier Enhancement for Eczema Prevention (The BEEP Study)

Understanding the long-term management of eczema

Skincare intervention in Nurses

Eczema Blues

New NEA post: Atopic Dermatitis Research Network needs trial participants

This week you’ll find me blogging over at the National Eczema Association website. I interviewed Donald Leung of National Jewish Health about the Atopic Dermatitis Research Network. Three years in to a $ 42M program to investigate the links between genetics and our susceptibility to skin infections, the ADRN is registering patients with the NIH before proceeding with clinical trials.

They still need black and Hispanic patients to sign up–eczema, genetics, and skin pathogens are different for different ethnic groups. The better your demographic is represented in the trials, the more that scientists will learn that applies to you.

The ADRN has centers in Boston, Chicago, Denver, Los Angeles, Portland OR, and Rochester NY.

If you’re interested in participating, email Judy Lairsmith at National Jewish or call 1-888-413-5852.
End Eczema