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Two Acne-Zapping Smartphone Apps Shut Down; FTC On Lookout For Others

This article was originally published in The Rose Sheet

Smartphones can do a lot of things, but curing acne is likely not one of them.

At any rate, scientific evidence was lacking for a pair of smartphone applications packaged as acne-treating software, whose marketers have agreed to drop their “baseless claims” under settlements with the Federal Trade Commission, announced Sept. 8.

The makers of AcnePwner, sold in Google’s Android Marketplace for $0.99, promised consumers they could “kill acne with this simple, yet powerful tool!”

Meanwhile, AcneApp, available through Apple’s iTunes Store for $1.99, was marketed on a misrepresented dermatological study, according to FTC.

“When you make health claims, the ground rules don’t change. You have to have evidence to back them,” said Jim Prunty, FTC staff attorney for advertising practices, adding: We’re aware that there are more apps out there.”

Both apps allegedly enabled mobile devices to treat acne by emitting light of certain wavelengths, and both have been pulled from the market.

Claims Inspire Thousands Of Downloads

AcnePwner app users were instructed to treat their skin with the appropriate colored light – blue to eliminate bacteria, red to heal skin and amber to help repair skin – by holding the screen of their mobile device close to the affected skin area for two minutes “as often as desired,” according to app instructions on AdroLib.com, a site that catalogs apps available for Android phones.

The marketer recommended that consumers with “stubborn acne” alternate between red and blue lights. The app was downloaded an estimated 3,300 times, according to FTC.

Reviews on AdroLib.com were mixed. “I love it!!! A+++!” said commenter Bill. Kevin, on the other hand, remarked: “Don’t work for me. Makes me wonder if you guys are getting paid to say these things.”

FTC determined that claims for AcnePwner were unsubstantied. The app’s creator Andrew N. Finkle will pay $1,700 in penalties under the terms of the settlement.

Marketed by DermApps’ Koby Brown and Gregory W. Pearson, AcneApp claimed to “fight bacteria” and “heal skin,” as well as “improve skin health without prescription drugs,” according to FTC.

The app delivered alternating blue and red light – which in the visible light spectrum have wavelengths in the neighborhood of 475 nanometers and 650 nm, respectively – via users’ iPhones. It was downloaded some 11,600 times.

The company claimed the app was developed by a dermatologist and cited a study published in the British Journal of Dermatology allegedly demonstrating that red and blue light treatments eliminate p-acne bacteria, according to FTC. Consumers were advised to hold their device’s display screen next to affected skin for a few minutes daily while the app was activated.

According to FTC, there is inadequate evidence to support the purported improvements that can be achieved through the app’s use. Furthermore, the agency says, “the marketers of AcneApp falsely claimed that the study in the British Journal of Dermatology proves that blue and red light therapy ... is an effective acne treatment.”

In reality, study results have been less definitive. In a meta-analysis published in June 2009 in BJD, study authors F.L. Hamilton, et al., of Imperial College London, concluded that in published clinical trial literature, “some forms of light therapy were of short-term benefit. ... However, very few trials compared light therapy with conventional acne treatments, were conducted in patients with severe acne or examined long-term benefits of treatment.”

Whatever the benefit of attacking acne with light, FTC Chairman Jon Leibowitz offered his take on the feasibility of translating that technology to one’s personal phone: “Smartphones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that.”

AcneApp’s owners will cough up $14,294 to settle with FTC.

Surviving Acne App Uses Blue Light, Blue Gem

FTC’s action against chromotherapy-based anti-acne apps has left at least one option available to consumers – United Holdings Group’s Anti-Aging App, which offers 10 targeted treatments, including Acne Clear.

According to the company, its treatments – which also include Wrinkle Eraser, Cellulite Buster, Skin Cleanser, Dark Circles & Puffy Eyes, Stretch Marks & Scars and Hair Growth Stimulator – use different combinations of light and sound wavelengths to “wake up cells” and rejuvenate skin.

Acne Clear, for example, uses blue light “to help clear and detox the skin.”

For each of its treatments, United Holdings identifies not only the light frequency used, but also some characteristics of the color and a related gemstone, which appears on the screen of the user’s mobile device. For Acne Clear the firm notes that “blue deals with willpower and is related to self-expression and the ability to communicate our needs and requirements.” The Lapis Lazuli, a blue stone, appears on the screen.

As with other apps of its kind, consumers are instructed to hold the phone one to three inches from the face or body. The firm recommends two 14-day treatment cycles each month, or about one treatment per day.

“The more treatments you take, the more the cells start to expand and that’s when you start to notice results,” United Holdings Vice President Danny Salomon asserted in a December 2009 interview with “The Rose Sheet” (Also see "Anti-Aging Skin Treatment Over The Phone? Developer Has New App For Apple" - HBW Insight, 7 Dec, 2009.).

In a Sept. 12 email, the exec offered his interpretation of the FTC action against AcnePwner and AcneApp. It’s not that the apps do not work, but that frequently a “mobile device will not produce the amount of energy needed to see results,” he suggested.

Salomon, who has not been contacted by the FTC, said his firm’s app has “gotten great reviews and results” mainly for the iPad and tablet versions because “the screen is bigger and emits a more powerful energy.”

United Holdings’ light-color and sound therapies are based on treatments performed with the Lulum Energy Device in doctor’s offices and medical spas, according to Salomon. Marketed by Amaruka USA, Lulum is available to professionals for about $75,000, Salomon said.

A Far Cry From Pro-Level Light Technologies

In recent years, a number of light-based devices have launched offering professional-type aesthetic therapies that can be self-administered by consumers at home.

Among acne-treatment devices designed for home use is Oregon Aesthetic Technologies’ ANSR, designed to kill acne-causing bacteria with narrow-band, high-intensity blue- and red-light wave applications, the firm says (Also see "Battle Of Anti-Acne Devices Heats Up; Prescription Claro Is First To Use IPL" - HBW Insight, 16 Feb, 2009.).

As devices move from professional to consumer home-use settings, they necessarily undergo modifications to ensure safety, as pointed out by dermatologist and laser surgeon Arielle Kauvar in a September 2009 interview.

“For these [at-home] devices to be safe,” she said, “they have to be much lower power and they also have to be safe to use on all skin types, because even in a professional setting there are devices that can be used on some people and not others. ... So the limitations are so great in terms of the safety issue, the question is how effective they'll really end up” (Also see "Laser Surgeon Says Home-Use Aesthetic Devices Could Fill Niche" - HBW Insight, 28 Sep, 2009.).

That question seems all the more relevant when light therapy is taken down another notch from specialized home-use devices modeled after professional systems to the level of mobile phone delivery.

FDA Proposes Narrow Focus In Medical Apps

Given the growing number of health-related software apps available to consumers in the mobile marketplace, FTC likely will remain active in the area.

“When you make health claims, the ground rules don’t change. You have to have evidence to back them,” Jim Prunty, staff attorney for advertising practices at the FTC, said Sept. 12.

“We’re aware that there are more apps out there,” he added, noting that FTC cannot comment on investigations in progress.

FDA also has gotten involved in the sector, issuing draft guidance in July for mobile medical applications.

In a release, the agency cited data suggesting that 500 million smartphone owners worldwide will be using a healthcare-related app by the year 2015. Current apps include calorie counters and other weight-watching mechanisms as well as apps that help diabetics manage their blood-sugar levels.

Generally, FDA seeks to encourage the development of new software apps to promote health and well-being.

However, as noted by FDA policy advisor Bakul Patel in a July 19 post on the agency’s website, “there are advantages to using medical apps, but consumers and health-care professionals should have a balanced awareness of the benefits and risks.”

In its guidance, FDA proposes to actively oversee a “small subset” of medical apps, namely those “that present the greatest risk to patients when they don’t work as intended.”

Subject to public comment through October 19, FDA’s guidance identifies apps that serve as accessories to FDA-regulated medical devices – like an app that would enable a doctor to view medical images on an iPad and make a diagnosis – as items of interest.

The agency also prioritizes apps that transform a mobile platform into a regulated medical device – for example, an app that converts a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

By Suzanne Blecher

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