ASA Adjudication on Sanofi-Aventis

Ad

A press ad for an injected dermal stimulatory agent was headlined “Natural looks for longer”. Text stated "From an early age your body produces less collagen, the substance your skin needs for a firm and youthful appearance. Sculptra stimulates your natural collagen production to help smooth lines and wrinkles, and restores facial contours, helping you to look younger naturally for up to 2 years after treatment.” The ad also featured before and after pictures of a woman’s face and text stated “The photos show results of treatment with Sculptra and have not been retouched. Individual results can differ."

Issue

The complainant challenged whether:

1. the claim "Sculptra stimulates your natural collagen production to help smooth lines and wrinkles and restores facial contours, helping you to look younger naturally" could be substantiated;

2. the claim "for up to 2 years after treatment' could be substantiated; and

3. the before/after images were accurate and representative of the results that could be achieved.

CAP Code

Response

1. Sanofi-Aventis (Sanofi) provided several journal articles and clinical studies in support of the claims, which showed that Sculptra, also known as Ply-L-Lactic Acid (PLLA), was not a filler, but a dermal stimulatory agent that was responsible for producing a fibrous tissue response that could be injected to restore volume to the face.  The studies compared the product to dermal fillers and looked at the efficacy of the product on the skins of mice and humans, including studies which looked at the effects on people who were HIV positive.  

2.  They said the evidence showed that the results looked natural, were safe and could last for 40 months, but they said they had been conservative in representing the length of time the treatment could last in the ad, to avoid raising patient expectations.

3. They believed the photos were representative and provided additional results and photos showing the effects of Sculptra on patients, along with patient and doctor consent.

Assessment

1. Not upheld

The ASA took expert advice.  We noted that some of the studies provided by Sanofi had some connection to the manufacturer, but that the substantiation also included independent studies.  We also noted that a large proportion of the evidence was based around tests on HIV patients, but there were several case reports on non-HIV patients which also assessed the efficacy of the product.  We understood from the expert that Sculptra worked by inducing local inflammation, which encouraged collagen deposition, but that the product was not itself a filler and did not give instant results.  We understood that the evidence showed that Sculptra could induce some collagen production and that the evidence therefore suggested that Sculptra could help smooth the skin and help restore facial contours, as claimed.  We noted the expert's explanation that it was generally considered that the smoothing of lines and wrinkles on the face gave a younger appearance, and considered that consumers who were interested in having that kind of treatment were likely to be aware that the product was injected and would have some understanding of what the process involved, and would understand the claim "helping you to look younger naturally" in that context.    

We concluded we had seen sufficient evidence to support the claims in the ad.

On that point, we investigated the ad under CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health & beauty products and therapies), but did not find it in breach

2. Not upheld

We noted that some of the studies suggested the effects could last up to 36 or 40 months.  We also noted that there was a large body of clinical experience across multiple studies that the effects were long-lived.  We understood that much of the evidence for the claim that the effects lasted "up to two years after treatment" had been taken from case reports and was mainly anecdotal, but that several hundreds of patients, who had been treated with Sculptra, were associated with the anecdotal claims, and the reporting of long-lived effects was vast and consistent.  

On balance we considered we had seen sufficient evidence to accept the claim the effects lasted "up to two years after treatment" and concluded that the efficacy claims had been substantiated.

On that point, we investigated the ad under CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health & beauty products and therapies), but did not find it in breach.

3. Upheld

We noted that the Before and After photos used different lighting and colour casts and that the photos were reproduced at different sizes.  We also noted that the models expression and make up was slightly different in each shot.  We considered that changing the lighting, light angle, colour or framing could have a significant effect on the appearance of the model.  We acknowledged that the model might be considered to look younger in the After shot, but considered that the differences in the way the photos were produced could misrepresent the effects of the treatment and concluded that the images were misleading.

On that point, the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health & beauty products and therapies).

Action

The ad must not appear again in its current form.

Adjudication of the ASA Council (Non-broadcast)