UK ASA ruling on claims for OmegaLabs’ Dermalex Eczema

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Posted 21 December 2016

OmegaLabs took the MCC to court recently, as mentioned in a GroundUp article.

Coincidentally, a complaint had been laid in the UK at the ASA against claims being made for one of their products: a press ad for Dermalex Eczema promoted a skin treatment cream for eczema. The advert stated, “AS EFFECTIVE AS A STEROID CREAM¹”. A footnote for the claim stated “¹Average symptom improvement over 6 weeks, when compared to Hydrocortisone 1% in petrolatum-cetomacrogol”. In the right-hand circle, text stated, “HYDRATES BETTER THAN AN EMOLLIENT²”. A footnote for that claim stated “²emollients containing unguentum leniens”. In the middle of the Venn diagram, text stated “BREAKTHROUGH ECZEMA TREATMENT”. A number of high street pharmacists’ logos were shown towards the bottom of the ad.

A complainant argued that the claims were not true.

The UK ASA agreed.

ASA Ruling on Omega Pharma Ltd

Omega Pharma Ltd

Date: 21 December 2016
https://www.asa.org.uk/Rulings/Adjudications/2016/12/Omega-Pharma-Ltd/SHP_ADJ_324180.aspx

Complaint Ref: A16-324180

Background

Summary of Council decision:

Three issues were investigated, all of which were Upheld.

Ad

A press ad for Dermalex Eczema, seen on 18 October 2015, promoted a skin treatment cream for eczema.

The ad showed a Venn diagram above a picture of the product. In the left-hand circle, text stated, “AS EFFECTIVE AS A STEROID CREAM¹”. A footnote for the claim stated “¹Average symptom improvement over 6 weeks, when compared to Hydrocortisone 1% in petrolatum-cetomacrogol”. In the right-hand circle, text stated, “HYDRATES BETTER THAN AN EMOLLIENT²”. A footnote for that claim stated “²emollients containing unguentum leniens”. In the middle of the Venn diagram, text stated “BREAKTHROUGH ECZEMA TREATMENT”. A number of high street pharmacists’ logos were shown towards the bottom of the ad.

Issue

GlaxoSmithKline Consumer Healthcare (UK) Trading Ltd challenged whether the following claims were misleading:

1. “AS EFFECTIVE AS A STEROID CREAM”;

2. “HYDRATES BETTER THAN AN EMOLLIENT”; and

3. “BREAKTHROUGH ECZEMA TREATMENT”.

CAP Code (Edition 12)

Response

1. & 2. Omega Pharma Ltd said the product was a class IIa medical device which was appropriately registered in the EU. They explained that there were two common treatments for eczema conditions: emollients that were applied topically to leave a film on the skin protecting it from moisture loss and reducing dryness; and topical corticosteroids that targeted inflammation and therefore reduced redness, and were often used in the instance of flare-ups. They said the former did not address the underlying inflammation and the latter did not moisturise the skin, and could only be used for short periods. The two were therefore often used together. They believed Dermalex Eczema Cream was unique in that it was used both for skin moisture retention and to treat flare-ups.

Omega Pharma said hydrocortisone cream was the commonly used steroid cream for treating eczema symptoms, and that it was a suitable comparator for Dermalex because both products were indicated for the treatment of mild to moderate atopic dermatitis. They acknowledged that other steroid creams might be recommended, and the ad therefore explicitly stated ‘a’ steroid cream to clarify that the comparison was against one type of steroid cream rather than against all steroid creams.

They provided us with a study in support of the claims, which they said was expected to be published imminently. They said peer review was being finalised. They said the study showed Dermalex was as effective as 1% hydrocortisone in reducing clinical symptoms of mild to moderate atopic dermatitis after six weeks, based on SCORAD reduction – a severity score used for atopic dermatitis – and other factors.

They said the study also showed that Dermalex showed a significantly greater decrease in SCORAD than the emollient after both three and six weeks. It also showed the highest improvement in skin hydration among all the different treatment types. They said the emollient used was one containing unguentum leniens (cold cream based emollient) as a common over-the-counter emollient and suitable comparator for Dermalex. They explained that they had updated the ad so it would say ‘emollients containing cold cream’, instead of using the Latin name, to provide further clarity to consumers.

3. Omega Pharma said Dermalex had been shown by the above study to have superior skin protection and moisture properties to an emollient, and to be as effective as 1% hydrocortisone cream. They said traditional treatment of eczema required the use of both an emollient and a steroid cream, which could not be applied in the same step. They believed therefore that the unique formulation of the product provided a breakthrough in eczema treatment because it addressed the key symptomatic needs in a single product that had not previously been available in the UK.

Assessment

1. Upheld

The ASA considered that consumers would understand the claim “AS EFFECTIVE AS A STEROID CREAM” to mean that Dermalex Eczema was generally as effective as steroid creams available across the market, in that it could alleviate the symptoms of eczema to the same extent and within a similar timeframe. We understood that there were a number of different steroid creams of differing strengths available, some of which could be purchased over the counter and some of which required a prescription. We considered that consumers who had eczema would understand that such differences existed, and given that the ad promoted an over-the-counter product that was available in a number of high street pharmacists, were likely to assume the comparison was with those steroid creams that did not require a prescription. While we noted that the footnote text explained that the comparison was solely against Hydrocortisone 1% cream (a mild steroid available without a prescription), we considered that the text lacked prominence and, nevertheless, was insufficient to counteract the overall impression that the comparison was a general one against steroids that were available over the counter.

We reviewed the one study provided and noted that it had not been peer reviewed at the time the ad appeared. We also noted that it involved a relatively small sample with two subject groups of 48 and 47 for each comparison (Dermalex versus a steroid cream, and Dermalex versus an emollient). Further, although we understood that the product was suitable for children over six years old, no children had been included in the study; the youngest participant was 21. We also noted that the confidence intervals for the results obtained were very broad and we had concerns that the blinding could have been undermined by the way the products were labelled and provided to the participants.

We understood that only one steroid cream had been included in the study. We considered that the comparison against that particular steroid cream would not necessarily be representative of other steroid creams available on the market more generally, such as those containing a steroid other than hydrocortisone.

In addition, we understood that steroid creams were typically for short-term use, and that users were generally directed to apply them for up to a week to ten days, and to cease application and seek medical advice from a doctor or pharmacist if their symptoms persisted. As stated above, we considered that, in the absence of any prominent qualification to the contrary, consumers would expect a product that claimed to be “as effective” as a steroid cream to result in a comparable improvement in the symptoms of eczema to that achieved by an over-the-counter steroid cream when used for the advised period of time. We noted, however, that the study lasted six weeks and the first measurement was collected after three weeks. There was no data to compare the results after the typical application period for an over-the-counter steroid of a week to ten days. We therefore considered that the study had not demonstrated that Dermalex Eczema was as effective as the steroid cream it was compared against.

In light of our concerns regarding the study, and because the claim implied that the comparison applied to over-the-counter steroid creams generally, and that the results would be achieved within a similar time to those achieved by steroid creams, when that was not the case, we concluded that the claim was misleading.

On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.33 (Comparisons with identifiable competitors) and 12.1 (Medicines, medical devices, health-related products and beauty products).

2. Upheld

We considered that consumers would understand the claim “HYDRATES BETTER THAN AN EMOLLIENT” to mean that the product was generally more effective than emollient creams available across the market in preventing moisture loss from the skin. We understood that there were numerous types of emollient available as an eczema treatment, which were typically available over the counter. We acknowledged that the footnote referred to “emollients containing unguentum leniens” but, as above, noted that the text was not prominent, and considered that it was not sufficient to counter the overall impression that the product was generally as hydrating as emollients available across the market.

The one study provided included a subject group that was used to compare the efficacy of Dermalex Eczema versus the application of an emollient. Only one emollient was used, however, and the study had not demonstrated that the emollient used was representative of emollients in general. In light of that, and given our concerns regarding the methodology of the study used as the basis of the claim, as set out in point 1 above, we concluded that the claim was misleading.

On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.33 (Comparisons with identifiable competitors) and 12.1(Medicines, medical devices, health-related products and beauty products).

3. Upheld

The “Breakthrough” claim appeared in the centre of a Venn diagram, in the middle of the other two claims. We considered that consumers would interpret this claim to mean that the product constituted a breakthrough treatment because it was the only product that was as effective as a steroid cream and more hydrating than an emollient.

Typically, we considered that advertisers wishing to make a breakthrough claim regarding a product should provide a body of evidence to substantiate that claim. We noted, however, that Omega had only provided one study of 95 participants to support their breakthrough claim. Further, given our concerns regarding the study as discussed in points 1 and 2 above, we concluded that the claim “BREAKTHROUGH ECZEMA TREATMENT” had not been substantiated and was misleading.

On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.33 (Comparisons with identifiable competitors) and 12.1 (Medicines, medical devices, health-related products and beauty products).

Action

The ad must not appear again in its current form. We told Omega Pharma Ltd not to mislead when making breakthrough claims or comparisons with other products. We told them not to state or imply that their products were as effective at treating eczema symptoms, or better at hydrating the skin, in comparison to other products unless they held adequate evidence to substantiate those claims.

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