By Arthur James,2014-05-16 00:37
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    DermaRadiant Anti-Wrinkle Complex


Direct response advertising for the DermaRadiant Anti-Wrinkle Complex (“Anti-

    Wrinkle Complex”), marketed by DermaRadiant Beverly Hills (“DermaRadiant”)

    was brought to the attention of the Electronic Retailing Self-Regulation Program

    (“ERSP”) pursuant to an anonymous competitor challenge. The website

    advertisement for DermaRadiant Beverly Hills, includes advertising for the

    DermaRadiant Anti-Wrinkle Complex and the following core claims regarding

    the efficacy of the product:

    I. Product Performance Claims

    ? “In Clinical Trials Lasting 56 days, Volunteers Observed: 44% to 98%

    decrease in deep wrinkles; 350% increase in collagen synthesis; 15%

    improvement in skin tone; 14-16% decrease in skin roughness”

    ? “…long-term restoration and healing of past damage.”

    ? “…will change your skin and your life forever.”

     II. Ingredient Claims

    ? “…smooth wrinkles from 45-98%”

    ? “…improve skin tone and texture”

    ? “…protect from free radical damage”

    ? ”…stimulate the growth of new cells, restoring younger skin.”

    ? Our ingredients also improve skin tone and texture, protect from free

    radical damage, and actually stimulate the growth of new skin cells

    restoring younger skin.”

     III. Comparative Claims

    ? “The DermaRadiant Anti-Aging Solution Will Change Your Skin and

    Your Life Forever! No Risky Injections. No Costly Doctor Visits and

    Prescriptions. No Painful Surgery.”

    ? “There simply is not a better or more effective product available at any

    price today.”

    ? Our commitment as always is to stay at the forefront of the skin-care

    industry by bringing our clients the absolute best products on the


    At the outset, ERSP noted that the testimonial claims at issue in the challenge were enumerated on the company website under both the DermaRadiant Anti-Wrinkle Complex and the DermaRadiant Ageless Eyes product, a companion product that was the subject of a simultaneous challenge. Upon examining the testimonials in context, ERSP determined that the claims were more relevant to the Ageless Eyes product and have been addressed collectively herein


    DermaRadiant notified ERSP at the beginning of the inquiry that it was in the process of changing the website to clarify the difference between both of DermaRadiant’s products: Anti-Wrinkle Complex and Ageless Eyes. For

    example, originally, the performance attributes of Dermaxyl or Matrixyl 3000 (the active ingredients in the product) , were kept separate on the DermaRadiant website. The marketer has since modified the website to now, collectively, refer to the performance attributes of the ingredients (i.e., “Dermaxyl/Matrixyl 3000”).

    DermaRadiant indicated that all testing of this product was conducted by Sederma Inc., the company who created the active ingredients for the Anti-Wrinkle Complex. Both active ingredients are contained at a 3% level in the Anti-Wrinkle Complex and the marketer’s two studies had an in-vitro and an in-

    vivo component.

    The marketer informed ERSP that skin aging leads to a thin, dry, rough epidermis, and is no longer able to fulfill its protective purpose. This leads to a decrease in the resistance to chemical and physical aggressions on the skin and a decrease in the waterloss barrier effect, creating dry skin. This dry skin no

    longer offers support and therefore becomes flaccid and less vascularized. The Anti-Wrinkle Complex was designed to combat these deficiencies by

    supplementing certain compounds, restoring the natural epidermal barrier and promoting dermal turnover.

    The in-vitro and an in-vivo examination study submitted by DermaRadient included an analysis of both the original Matrixyl as well as Matrixyl 3000 (which is an improved version of the original Matrixyl ingredient). The original Matrixyl was developed from a peptide fragment sequence, generally less than, or equal to, 20 amino acids derived from matrix proteolysis during coetaneous wound cleaning prior to healing. A combination of two peptides forms Matrixyl 3000.

    An in-vitro analysis of one peptide was conducted on human fibroblast cultures and demonstrated up to a 350% increase in collagen synthesis using the same concentration of Matrixyl contained in the product.

The in-vivo study was conducted over a 2 month period with 49 subjects

    applying Matrixyl 3000 to the crow’s feet surrounding their eyes. Two panels were conducted in this study, with 24 subjects testing Matrixyl 3000 against a

    placebo and a second panel of 25 subjects testing Matrixyl 3000 against original

    Matrixyl. Both panels used Matrixyl 3000 at a 3% concentration, the same

    concentration used in the Anti-Wrinkle Complex. Product performance was

    assessed using profilometry and image analysis, photography, and cutometry.

    The results showed that Matrixyl 3000 performed better than Matrixyl in wrinkle

    depth, density, and skin smoothing. After 56 days, use of Matrixyl 3000 resulted

    in a 44% reduction in the area occupied by deep wrinkles, a 15% reduction in the

    mean depth of the main wrinkle and an 18% reduction in its volume, and a 14%

    reduction in roughness with an accompanying 16% reduction in complexity (a

    surface lifting parameter).

A study conducted by Sederma on Dermaxyl, the second active ingredient in the

    Anti-Wrinkle Complex, also included both an in-vitro and in-vivo examination at

    a 2% concentration. The in-vivo trial was on 24 volunteers who used a daily

    application of a foundation cream or foundation cream base containing 2%

    Dermaxyl for 2 months. The marketer gathered the data used conventional

    impressions which were then digitally analyzed accompanied by video images of

    cutaneous responses. The results indicated a 10% to 13% reduction in the mean

    depth and volume of the main wrinkle; a 40 % reduction in the area occupied by

    deep wrinkles with a maximum of 98% reduction achieved (note: this does not

    mean the wrinkles were eliminated, but were instead, simply reduced to intermediate wrinkle stage), and a 24% reduction in the area occupied by

    intermediate wrinkles.

According to the marketer, its examination of the ingredients of DermaRadiant

    therefore substantiated its quantified claims that In Clinical Trials Lasting 56 days,

    Volunteers Observed: 44% to 98% decrease in deep wrinkles; 350% increase in collagen

    synthesis; 15% improvement in skin tone; 14-16% decrease in skin roughness.”


ERSP first notes its appreciation to DermaRadiance for its voluntary action in

    modifying the advertising during the pendancy of the inquiry.

    I. Product Performance Claims

    “Clinically proven” claims send a very strong message to consumers, and support for such statements is carefully scrutinized. In fact, many regulatory authorities

    often require two tests to support “clinically proven” claims. Although the test

submitted by DermaRadiant may provide adequate support for claims of general

    product performance, ERSP was concerned about the reliability of this one test as

    providing the necessary support for a clinically based claim. Although ERSP did not dispute the literal accuracy of the results reported from the study, it was

    concerned with the implication that the results were “clinically proven” when in

    fact, the results were not statistically significant. Accordingly, while ERSP does

    not object to a specific, accurate reporting of the data, it recommends that the

    marketer refrain from communicating that the results were “clinically” based.

ERSP agrees that the testing submitted on the product ingredients does show an

    improvement in the “appearance” of wrinkle depth and an improvement in skin

    texture as reported by its users. However, ERSP cautions DermaRadiant to be

    mindful of the context in which the performance claims are referenced. For

    instance, the results showed an improvement in the appearance of wrinkles, but

    did not conclude the product completely eliminated the wrinkles. As clarified in

    the extreme result of a 98% change, the Sederma study on Matrixyl states “this extreme value simply indicates that the deep wrinkles (.200) decreased to become

    intermediate wrinkles and not that the skin was totally smoothed.” Therefore, ERSP recommends that DermaRadiant clarify that its results indicate that the

    “appearance” of wrinkles and wrinkle depth was visibly improved, rather than being completely eliminated.

Further, the claim After 56 days of twice-daily application, volunteers

    experienced …350% increase in collagen synthesis…” may, in ERSP’s determination,

    be potentially inaccurate as the 350% increase in collagen synthesis was achieved from in-vitro testing rather than in-vivo testing. Although these results are

    accurate, ERSP feels that this claim is being miscategorized as an observation

    from clinical trials, when in fact this is not the case. ERSP recommends that this

    claim be modified and placed in proper context to represent the manner in which

    the results were obtained.

    Although ERSP did agree that the subjects who used DermaRadiant’s Anti-Wrinkle Complex did report improved skin tone and texture, ERSP did not agree

    that the testing provided confirmed DermaRadiant could “…actually stimulate the growth of new skin cells, restoring younger skin.” The in-vitro testing showed that

    Matrixyl 3000 increased collagen production, stimulated the growth of new cells,

    and protected against free radical damage. However, ERSP was troubled with

    the marketer’s use of the phrase “restoring younger skin, as neither the in-vivo or in-vitro testing provided results indicated a restoration (i.e., returning to its

    original condition) of the skin. ERSP therefore advises DermaRadiant to avoid

    restoration claims in future advertising when talking about the performance of

    the Anti-Wrinkle Complex.

Although ERSP did find that the studies conducted by Sederma did show skin

    improvement, both tests were conducted over a 56 day period. No testing was

    provided to ERSP that went beyond the 56 day trial for either the ingredients or

    the Anti-Wrinkle Complex as a whole, nor was there any follow-up information

    provided by the marketer. Without long-term testing on either the ingredients or

    the product, ERSP determined that permanency claims such as “long-term restoration and healing of past damageshould be discontinued until long-term

    evaluations can be conducted on the Anti-Wrinkle complex.

    II. Ingredient Claims

ERSP determined that the studies on Dermaxyl and Matrixyl 3000 conducted by

    Sederma, provided a reasonable basis for the claims “smooth wrinkles from 45-98%”; “improve skin tone and texture”; “protect from free radical damage”; and

    “stimulate the growth of new cells…” However, ERSP determined the testing did

    not support the claim “…restoring younger skin.” Moreover, ERSP was concerned about the range specified in the claim “smooth wrinkles from 45-98%” in concert

    with the representation that the product is clinically proven to reduce wrinkles 98%” on the main header of the DermaRadiant website. As indicated by the

    study administrators, 98% is the high end, an “extreme value” achieved by one study participant and is not representative of the results a consumer could expect

    to achieve. Further, as stated above, the study indicated that the Anti-Wrinkle

    Complex reduced the appearance of wrinkles in a subjective (i.e., non-clinical)

    setting. ERSP recommends that DermaRadiant modify the website header to

    reflect the range and accuracy of the results achieved in the Sederma study.

    Further, as stated above, ERSP recommends that DermaRadiant discontinue any

    restoration claims.

III. Implied Comparative Claims

ERSP determined that while it may be true that DermaRadiant does not

    necessitate injections or surgery, it would not be unreasonable for consumers to

    understand the claim as communicating that the Anti-Wrinkle product’s efficacy is comparable to Botox or plastic surgery. More specifically, ERSP is concerned

    that the statements when used in conjunction (“The DermaRadiant Anti-Aging Solution Will Change Your Skin and Your Life Forever! No Risky Injections. No Costly

    Doctor Visits and Prescriptions. No Painful Surgery.”) implies to consumers that the efficacy of DermaRadiant is comparable to Botox or plastic surgery.

ERSP concluded that, in future advertising, DermaRadiant may tout the Anti-

    Wrinkle Complex is a viable alternative to surgical procedures or injections, but

    also recommended that it discontinue using the claims together and refrain from

making permanency claims, until the time at which DermaRadiant can conduct

    more long-term testing on the Anti-Wrinkle Complex.

Additionally, because DermaRadiant has only provided monadic efficacy studies

    and has not provided any comparative data with respect to competitive cosmetic

    products on the market, it is recommended that the marketer discontinue

    unqualified superiority claims regarding the performance of its product such as

    “There simply is not a better or more effective product available at any price today.”


ERSP determined that DermaRadiant has provided a reasonable basis for their

    general performance claims, but did not agree that the results supported a

    “clinically proven” claim. ERSP also cautioned DermaRadiant to be more

    accurate in the presentation of these results to more accurately reflect the testing

    it possesses. ERSP determined that the general efficacy claims have been

    supported but, nevertheless, recommended DermaRadiant discontinue any

    performance claim pertaining to the restoration of skin. Lastly, without

    comparative testing, ERSP recommended that all permanency claims or

    comparative claims be discontinued.


Thank you for your review of the DermaRadiant website and claims. We are

    very pleased to have gone thru this process with limited mandates from the

    NARC and hope this speaks to the efficacy of our products and integrity of our


Copyright 2005. Council of Better Business Bureaus, Inc.

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