Background
Summary of Council decision:
Four issues were investigated, of which three were Upheld and one was Not upheld.
Ad description
A product listing on Amazon for “SCAR ERASE. Medical Grade Silicone Scar Sheets”, seen in June 2025 . The ad included the product name followed by text which stated “Soften and Flattens Keloid, Hypertrophic, Surgery, Injury & C-Section Scars – […] 6 Week Reusable Treatment…”.
Underneath, text included “ADVANCED MEDICAL-GRADE SCAR TREATMENT […] clinically proven to reduce the appearance of Keloid and Hypertrophic scars, whether old or new”, “Each strip can be use [sic] up to 2 weeks, delivering up to 6 weeks of treatment” and “Experience the magic of our silicone sheets for scars”.
One of the thumbnail images on the left side of the page featured a "Before & After" comparison of the model holding the product. In the "Before" image, she displayed a visible scar on her shoulder, while in the "After" image, she posed in the same manner but with the scar completely gone.
In front of an image of the product's packaging, a text box stated “MINIMISE SCAR [sic] AS FAST AS 6 WEEKS”.
The “Product Description ” section featured an image of a model holding the product. Text at the bottom of the image stated “86% REDUCTION IN SCAR TEXTURE”, “84% REDUCTION IN SCAR COLOUR”, and “68% REDUCTION IN SCAR HEIGHT”.
Issue
Alliance Pharma challenged whether:
- the ad made medical claims which breached the Code;
- claims such as “clinically proven to reduce the appearance […] scars, whether old or new”, “86% REDUCTION IN SCAR TEXTURE”, “84% REDUCTION IN SCAR COLOUR”, “68% REDUCTION IN SCAR HEIGHT” and the product name “Scar Erase” were misleading and could be substantiated;
- the claim “MINIMISE SCAR [sic] AS FAST AS 6 WEEKS” was misleading and could be substantiated; and
- the “before and after” photos were genuine and an accurate reflection of what could be achieved with the product.
Response
1. SJC&M Ltd t/a Scar Erase submitted a letter from the Medicines and Healthcare products Agency (MHRA) confirming the device registration of the product, and a copy of their UKCA Declaration of Conformity.
2. Scar Erase said that silicone-based scar treatments, in gel or sheet form, worked by creating an occlusive barrier that hydrated the skin, regulated collagen production and reduced fibroblast activity, helping to prevent and improve abnormal scarring. They provided evidence that they believed substantiated the efficacy claims made for their product. This comprised of a PhD thesis, a clinical trial, a peer-reviewed article, a clinical study and a non-clinical study. They also shared their Clinical Data Clinical Evaluation Plan, which outlined the safety, intended purpose, performance, and clinical benefits of the product. They further confirmed their commitment to removing these claims from the ad and all associated placements and expressed willingness to cooperate fully with the ASA.
3. To support the claim “MINIMISE SCAR [sic] AS FAST AS 6 WEEKS”, they submitted a literature review, a peer-reviewed clinical study and a randomised clinical trial, as above. They also cited an additional peer-reviewed article and a separate randomised controlled clinical trial, which were not provided in full. They further shared clinical guidelines and marketing material from competitors and highlighted that their advertising stated that visible improvements often appeared between four and six weeks. They said that they indicated that the scars may minimise in six weeks as substantiated by the evidence above, but could take longer. As such, marketing information stated that the timelines for improvement will vary person to person. Nonetheless, they added that they would remove this claim from the ad, and all associated placements.
4. They said that their before and after photos came with the disclaimer “Image for diagrammatical representative only, see our customer reviews for real life before and after’s!”. They added that they would remove this image from the ad, and all associated placements.
Assessment
1. Not upheld
The CAP Code stated medicinal or medical claims and indications could only be made for a medicinal product that was licensed by the MHRA, the Veterinary Medicines Directorate (VMD) or under the auspices of the European Medicines Agency (EMA), or for a medical device with the applicable conformity marking. In addition, the Medical Devices Regulations 2002 required that a medical device should be registered with the MHRA before it was placed on the market in Great Britain.
Because we had seen evidence that the product was registered with the MHRA and held the appropriate conformity marking, medical claims could be made for the product.
On that point, we investigated the ad under CAP Code (Edition 12) rule 12.1 (Medicines, medical devices, health-related products and beauty products), but did not find it in breach.
2. Upheld
The ad stated: “clinically proven to reduce the appearance […] scars, whether old or new”; “86% REDUCTION IN SCAR TEXTURE”; “84% REDUCTION IN SCAR COLOUR”; and “68% REDUCTION IN SCAR HEIGHT”. We considered that consumers likely interpreted the claims as directly related to the Scar Erase product and that the phrase “clinically proven” implied rigorous testing had been conducted. The reference to old or new scars suggested broad effectiveness, regardless of scar age or type, and further implied that studies had been carried out on both recent and long-standing scars. We therefore expected to see such evidence to support those claims.
We assessed the evidence provided. A qualitative literature review supporting silicone gel sheeting was submitted, but it lacked statistical analysis, standardised methods and formal study quality assessment. Scar Erase also submitted a non-clinical study on 10 volunteers measuring skin hydration, which did not involve scar patients or assess clinical outcomes. We considered these studies were inadequate to support the claims in the ad.
We then assessed the PhD thesis evaluating the use of silicone gel sheeting in the treatment of 125 patients with a total of 129 hypertrophic and keloid scars. We noted several limitations in the evidence provided. Scar improvement was assessed after only two months, offering a limited insight into long-term outcomes of scar appearances and the study was an unpublished academic thesis that had not undergone peer review. Furthermore, the study did not provide information on the age of the scars prior to treatment, and as such we could not evaluate the treatment’s effectiveness across different stages of scar development. We therefore considered it was not sufficient to substantiate the claims.
We next evaluated the randomised trial comparing silicone gel-filled cushions and gel sheeting in 32 patients with hypertrophic and keloid scars of differing durations. Both formats improved scar elevation, redness and firmness, with no significant difference in efficacy. However, we understood that there was no control group, therefore it was uncertain whether any improvement in scarring experienced by the patients was due to the silicone treatment, rather than other factors. We also considered that a group of 32 patients constituted a small sample size, which we considered too small for the results to be extrapolated to the wider population, and therefore insufficient to substantiate the claims made in the ad. We therefore considered the trial was not sufficient to substantiate the claims.
Scar Erase further submitted a peer-reviewed clinical study which evaluated over six months a self-drying silicone gel in 30 patients with hypertrophic and keloid scars. Applied twice daily for over 90 days, the gel showed significant improvements, reducing texture by 86%, colour by 84% and height by 68%. However, the advertised product used a silicone gel sheet worn once daily for up to 23 hours which differed from the treatment protocol in the study both in terms of dosage, frequency of application and the application format. We acknowledged that Scar Erase believed it was valid to apply results from studies on silicone gel to support claims related to silicone sheeting, on the basis that the randomised controlled trial discussed above found no statistically significant difference in efficacy between the two formats. However, we considered that the differences between formats in the dosage, frequency of application and user compliance were clinically relevant and could impact the effectiveness of treatment. Therefore, we considered that the evidence which related to the silicone gel was not relevant to the claims or product advertised. Additionally, the study was uncontrolled and unblinded, which meant we could not be certain the effects experienced by the participants were due to the treatment itself and may have introduced bias. We also considered that a sample size of 30 was not sufficient to demonstrate the effects of the treatment. Finally, we noted that only 13.33% of the scars assessed were older than six months, indicating that the results were primarily applicable to newer scars, rather than both older and newer scars as the ad indicated. For those reasons, we did not consider it was sufficient to substantiate the claims.
While some of the submitted studies supported the general effectiveness of silicone-based treatments in improving scar appearance, they did not provide adequate substantiation for the product advertised in relation to the claims made.
We concluded that these claims had not been substantiated and were therefore misleading.
On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.7 (Substantiation).
3. Upheld
The ad stated “MINIMISE SCAR [sic] AS FAST AS 6 WEEKS”. We considered consumers would interpret this to mean that the product could produce visible and meaningful improvements in scar appearance within six weeks of use.
We noted that the advertiser stated that their marketing information indicated that timelines for improvement would vary from person to person. However, we did not see this qualification presented in the ad itself. We considered that consumers would interpret the claims as promising consistent and rapid results for all users.
Scar Erase provided three of the same pieces of documentary evidence shared in relation to Issue 2: the literature review, the peer-reviewed clinical study and the randomised clinical trial. We considered they were not sufficient to substantiate this claim for the same reasons as outlined above, notably, because: the literature review was not a clinical trial; neither the peer-reviewed clinical study nor the randomised clinical trial were controlled; they both had a small sample size; and the treatment protocol did not reflect the advertised product.
We reviewed the additional peer-reviewed article and randomised controlled clinical trial cited in support of the claim. Scar Erase said that these demonstrated early improvements in scar characteristics, such as colour, elevation and pliability, typically beginning between four and six weeks of daily silicone application. However, as full copies of the article and trial were not provided, we were unable to assess the results or the methodology of the trial. Therefore, we did not consider they were sufficient to substantiate the claims.
We concluded that the claim had not been substantiated and was therefore misleading.
On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.7 (Substantiation).
4. Upheld
The listing featured a before-and-after photo, which we considered consumers would interpret as a genuine depiction of a model’s results from using the product, and as representative of the typical outcomes achievable with treatment. Scar Erase stated that their images were accompanied by a disclaimer: “Image for diagrammatical representation only, see our customer reviews for real-life before and afters!”. However, we did not consider this to be enough to counteract the impression that the image depicted authentic results. As we had not seen any evidence to substantiate that the image was genuine or representative of typical results, we considered the presentation was misleading.
The ad breached CAP Code (Edition 12) rules (Misleading advertising), (Substantiation) and (Exaggeration).
Action
The ad must not appear again in the form complained of. We told SJC&M Ltd t/a Scar Erase not to make any efficacy claims regarding their product or claims about the treatment period unless they had adequate evidence to substantiate those claims. Additionally, we had told them that their before-and-after photos must not exaggerate the product’s efficacy and that they needed to ensure they had relevant evidence to support the impression created by those images.
