Stiefel's MaxClarity "More Medicine," Severe Acne Claims Irritate Competitor

Stiefel Laboratories' claims suggesting its MaxClarity foam-based system can treat severe acne by delivering more medicine than alternative products and without irritation did not sit well with the competition.

The National Advertising Review Council's Electronic Retailing Self-Regulation Program sided with an anonymous challenger on multiple counts.

In its decision released Sept. 21, ERSP said Stiefel - a GlaxoSmithKline subsidiary - notified the watchdog that it would modify or discontinue a number of the claims even before an analysis began. Nevertheless, ERSP reviewed the offending claims in their original context.

ERSP took no exception to Stiefel's core product efficacy claims, which the advertiser backed with an eight-week, 28-subject open-label study and an evaluator-blinded, 8-week split-face study.

In the open-label study, total lesion count from baseline was 44.9 percent after four weeks and 56.9 percent after eight weeks. On the Investigator's Static Global Assessment scale, 42.9 percent of participants showed at least one grade of improvement as of week two, and 50 percent of subjects had improved by at least one grade as of week eight, the report notes.

According to ERSP, both studies "were independently conducted, provided statistically significant data and used two industry-accepted measurement techniques. ... It was concluded that the results of these studies sufficiently demonstrated that use of MaxClarity led to a meaningful improvement in acne in a significant number of the study subjects as measured by the efficacy parameters."

However, ERSP recommends Stiefel discontinue consumer testimonials and "before and after" depictions suggesting MaxClarity is an effective treatment for severe acne, as the company lacks adequate substantiation for such a claim. "Consumer endorsements themselves are not competent and reliable scientific evidence," the group notes.

"More Medicine" Claim Is Problematic

One of the advantages of Stiefel's MaxClarity system, according to the marketer, is that it features not one but two acne-fighting ingredients - benzoyl peroxide and salicylic acid.

The company claims that due to this distinction, MaxClarity "delivers more than 60 percent more medicine per dose," than Proactiv , Acne Complex or skinID , therapies marketed by Guthy-Renker, Murad and Johnson & Johnson's Neutrogena outfit, respectively, which derive their effects from the use of either benzoyl peroxide or salicylic acid, but not both.

ERSP agreed with the challenger that because the FDA acne monograph allows different maximum concentrations for benzoyl peroxide and salicylic acid - 10 percent and 2 percent, respectively - and because the ingredients have different mechanisms of action, it is inaccurate to compare MaxClarity's combined amount of active ingredient with the percentage of a particular ingredient in competing products.

Also, Stiefel should not imply "that the delivery of 'more medicine' correlates to superior performance if, in fact, that is not the case," ERSP says.

Stiefel indicated in future advertising it will emphasize the "efficiency" of its foam technology in delivering acne-fighting agents rather than the "absolute amount" of ingredient.

Foam Delivery Vehicle "First And Only"?

The broadcast and online advertising in question states MaxClarity is "the world's first and only acne-fighting foam system" providing enhanced delivery of anti-acne ingredients.

The challenger pointed out that other acne products come in foam form, including Clinique Solutions Treatment Foam and PanOxyl Acne Treatment Foam. While they may be individual products rather than acne-fighting systems, the claim is still misleading, said Stiefel's competitor.

ERSP recommends that Stiefel modify the language to qualify the competitive parameters.

The challenger also objected to the notion that "by virtue of its VersaFoam technology, which purportedly allows fast absorption into the skin's pores without causing any skin irritation, Steifel's three-component acne treatment is superior to all other competing products."

ERSP took issue with that implication as well, noting FDA's acne monograph requires benzoyl peroxide-containing products to include a label warning that the ingredient can cause skin irritation.

Stiefel has agreed to modify its claim to clarify that the product can be used "with little or almost no irritation."

ERSP "was not troubled" by Stiefel's assertion that foam delivery for acne ingredients is "the biggest new scientific breakthrough in the treatment of acne in over 40 years." Such a claim is "not inappropriate" as long as it is not presented in a way to suggest that the introduction of an OTC foam acne treatment represents a superior option to others.

Stiefel informed ERSP that it has discontinued its claim that MaxClarity is "doctor-recommended," which according to ERSP requires an advertiser to have "a random and statistically representative survey of doctors showing that a substantial percentage recommend the product and should be based on the actual experience of physicians in their ordinary practice."

Stiefel, which GSK acquired in 2009 for $2.9 billion, said it disagrees with ERSP's conclusions regarding the use of MaxClarity for severe acne, but accepts the recommendation and will modify advertising accordingly (¹ (Also see "Glaxo Augments OTCs With Stiefel Deal, Gains Strong Dermatology Foothold" - Pink Sheet, 27 Apr, 2009.)).

The firm added it is pleased ERSP recognizes its product is efficacious and when used as directed will result in clear skin. Stiefel has agreed to modify its advertising in accordance with ERSP's recommendations to support the self-regulatory process.

Overseen by the National Advertising Review Council and administered by the Council of Better Business Bureaus, ERSP offers a self-regulatory mechanism for the electronic direct-response industry.

MaxClarity launched in 2010 with commercials running on national cable networks and online advertisements targeted to social media networkers. The line is available at MaxClarity.com and Stiefel had no plans to introduce it to retail (² (Also see "Glaxo's Stiefel Labs Touts Penetrating Foam In MaxClarity Acne Treatment" - Pink Sheet, 30 Aug, 2010.)).

- Suzanne Blecher ( ³ [email protected] )