Ad description
A poster for Beauty Pie, seen on the London Underground Network on 17 December 2025. The poster featured an image of an individual wearing an LED mask. Text stated “SKIN TECH THAT’S LIGHT YEARS AHEAD […] C-WAVE FACIAL LED TREATMENT MASK […] CLINICALLY PROVEN TO REDUCE WRINKLES IN 4 WEEKS”. Smaller text towards the bottom of the poster read “Results from a 4-week study of 28 people aged 30-65”.Issue
The complainant challenged whether the claim “clinically proven to reduce wrinkles in 4 weeks” was misleading and could be substantiated.Response
Beauty Pie Ltd said that the C-Wave Light Facial LED mask was marketed and distributed by Beauty Pie, but manufactured by another company. They said the device was marketed exclusively for cosmetic purposes, and therefore was not required to carry a UKCA medical device conformity marking.Beauty Pie believed the claim “clinically proven to reduce wrinkles in 4 weeks” was substantiated by two product-specific clinical studies on the C-Wave Light Facial LED mask (the FaceLITE device) and a body of evidence comprised of six peer-reviewed clinical studies on equivalent technology. They said the text “results from a 4-week study of 28 people” referred to the first study on the FaceLITE device. Participants underwent a course of three treatments per week for four weeks. Prior to each light treatment, participants used skin cleansing pads and applied a hydrogel mask. The results demonstrated a significant reduction in wrinkles. They said the study showed there was a 38.7% reduction in wrinkle smoothness and a 37.6% reduction in wrinkle number and width. At the conclusion of the treatment, 92% of subjects either agreed or strongly agreed with the statement that their “fine lines appear less visible”. Beauty Pie stated that sample sizes of 20 to 25 subjects were routinely accepted by other regulators. They also referenced international Good Clinical Practice, which required that sample sizes in clinical trials be scientifically justified to ensure they were large enough to detect a meaningful effect, but small enough to minimise risk to participants.
The second study on the FaceLITE device involved 20 participants and was conducted without the hydrogel mask but otherwise followed the same treatment protocol. Beauty Pie said the study demonstrated an average visible reduction in lines and wrinkles of 20% when comparing the appearance of wrinkles at the beginning of the study and one week after the final treatment. Skin roughness improved by an average of 14%. They believed the study demonstrated that the FaceLITE device alone provided a measurable reduction in wrinkles.
Beauty Pie said that the cumulative dose of light delivered by the FaceLITE mask was comparable to, and slightly exceeded, that of an equivalent product used in clinical settings. The FaceLITE mask emitted light at wavelengths 830 nm (+/-17.5 nm) and 633 nm (+/-15 nm). The equivalent product emitted light at the wavelengths 830 nm (+/- 5 nm) and 633 nm (+/-6 nm). The FaceLITE mask sat directly on the skin, whereas the equivalent product was formed of panels positioned a few centimetres away from the face. Beauty Pie believed that although the distance between the individual and the light source was different, the cumulative dose of light delivered to the skin by each device was practically the same. They referenced the inverse square law, which described how light became weaker the further away an object was from the light source. Therefore, although the equivalent product used in clinical settings had a higher intensity, they believed that the FaceLITE device delivered light within the same range shown to be effective in clinical studies. They said the total light intensity of the FaceLITE device at source was 30 mW/cm2 (milliwatts per square centimetre). The total light intensity of the equivalent technology at source was 160 mW/cm2. That fell to 40 mW/cm2 at 2 cm, 18 mW/cm2 at 3 cm and 6 mW/cm2 at 5 cm. Beauty Pie provided four studies in relation to the equivalent product, and two studies in relation to novel products made by the same manufacturer, which they believed demonstrated the efficacy of the specific wavelengths used by the FaceLITE device over similar timeframes. Taken altogether, the two FaceLITE studies and six studies on similar technology represented a total sample of 250 subjects. Final assessments for safety and efficacy were conducted on 197 of those subjects. Beauty Pie believed that represented a robust body of clinical evidence supporting the efficacy of the FaceLITE device.
Assessment
UpheldThe ASA considered consumers would understand the claim “clinically proven to reduce wrinkles in 4 weeks” to mean that the LED mask could visibly reduce the appearance of wrinkles within four weeks of use, and had been scientifically proven to do so. We considered that impression was reinforced by the text “skin tech that’s light years ahead”, which suggested that the product was revolutionary, market-leading and advanced enough to have a noticeable effect. We therefore expected Beauty Pie to hold robust, product-specific evidence to support the claim.
We assessed the first FaceLITE study provided by Beauty Pie. The study assessed the efficacy of the FaceLITE device in reducing the signs of skin ageing, as measured by changes in wrinkles, skin texture and elasticity. Participants underwent three 10-minute at-home treatments a week for four weeks, with a follow up in week five. We understood the study results indicated a decrease in the smoothness, number and width of wrinkles. A self-assessment was also carried out by the participants, 92% of whom agreed or strongly agreed with the statement “my fine lines appear less visible” after four weeks of treatment.
We considered the study had a relatively small sample size of 28 participants, and had not seen any calculations or analysis to demonstrate the sample was sufficient to produce reliable, statistically significant results. We also considered the study’s methodology was a significant limitation. The investigators and participants were not blinded, and there was no control or placebo group to help demonstrate that any improvements in the appearance of wrinkles were due to the FaceLITE device, rather than other factors. Prior to each use of the LED mask, participants were required to use cleansing skin pads designed to exfoliate the face, and apply a hydrogel mask designed to maximise the absorption of skincare products during treatment. We understood that those elements were not supplied with the LED mask sold by Beauty Pie. The study did not consider or control for the possibility that the hydrogel mask could have affected the visible appearance of wrinkles. We therefore considered the reported improvements in the appearance of wrinkles could not be attributed to the FaceLITE device alone, and the study was insufficient to support the claim regarding the product’s efficacy.
We next considered the second study on the FaceLITE device, which applied the same treatment regime as the first study without the use of the hydrogel mask. The study reported an average visible reduction in lines and wrinkles of 20%, and that skin texture improved by an average of 14%. However, we considered the sample size of 20 participants was relatively small; no sample size calculation was included to demonstrate the sample was sufficient to ensure the validity and generalisability of the results. Furthermore, the study noted that participants’ self-assessment of wrinkle improvement was not as substantial as reported in previous literature: 65% of participants neither agreed nor disagreed with the statement “my fine lines appear less visible”; 20% agreed with the statement; and 15% said they agreed somewhat. We considered that did not support the impression created by the ad that the product was revolutionary and consumers could expect a visible reduction in the appearance of wrinkles immediately after four weeks of use. Some methodological limitations from the first FaceLITE study were repeated, as there was no control group, the participants and investigators were not blinded, and neither study had been published or peer reviewed. We therefore considered the second FaceLITE study was also insufficient to support the claim that the device could reduce wrinkles in four weeks.
We then assessed the studies that Beauty Pie had provided which assessed the efficacy of other LED devices. We understood four of those studies assessed a product used in a clinical setting which Beauty Pie believed delivered a comparable dose of light to the FaceLITE device. However, the FaceLITE device was a mask worn on the face; the product assessed in the studies provided was comprised of panels positioned a few centimetres away from the subject’s nose. We acknowledged Beauty Pie’s assertion that the cumulative dose of light delivered by both products was essentially the same, but noted that there were still key differences between the devices. The FaceLITE device delivered red and infrared light at the same time. The comparative product delivered only one type of light during each use. Red light and infrared light were delivered separately in alternating sessions. The FaceLITE device was administered at home, whereas the comparative product was administered in a clinical setting. The length and frequency of sessions also varied between the studies and differed from the recommended duration and frequency of use of the FaceLITE device. Furthermore, the ad specifically stated that the FaceLITE device was “clinically proven to reduce wrinkles in 4 weeks”. Consumers were therefore likely to expect any evidence to support that claim to specifically examine the results of the FaceLITE device immediately after four weeks of use. However, in three of the four studies on equivalent technology, sessions with the LED device were administered over five weeks, rather than four, and follow-up assessments were conducted six, nine and twelve weeks after treatment began. We therefore considered those studies were insufficient to substantiate the claim that the FaceLITE device was proven to reduce wrinkles in four weeks. In the fourth study, participants received two LED treatments a week for four weeks. We noted that the methodology of the study was more robust than the others had provided, as it was double-blinded, randomised, and included a placebo group, although a high number of participants in the control group did not complete the study due to dissatisfaction with the treatment. However, given the study was not specific to the advertised product, we considered that study alone was insufficient to demonstrate that the FaceLITE device itself was clinically proven to reduce wrinkles in four weeks.
Finally, we considered two studies Beauty Pie had provided on novel LED devices. The first of those studies concerned the use of a handheld device. Subjects received alternate exposures to near-infrared light for 20 minutes and red light for 30 minutes for a period of four weeks and received eight light treatments in total. This differed from Beauty Pie’s device, which delivered infrared and red light combined for 10 minutes, and was recommended for use three to five times a week, and we therefore considered the devices were not comparable. The second study, which examined the effects of an under-eye LED device, had an extremely small sample size of 11 participants, which we considered significantly limited the generalisability of the findings. As the device studied was only for use on the under-eye area, we considered it could not be directly compared to the FaceLITE device. The study found that the reduction in wrinkles reported was not statistically significant. We therefore considered that study was also insufficient to substantiate the ad’s claim.
Because the product-specific studies provided by Beauty Pie were unpublished and had methodological limitations, we considered that they were insufficient to substantiate the claim that the C-Wave Light Facial LED mask was clinically proven to reduce wrinkles in four weeks. We also considered that, for the reasons set out above, the supplementary studies on different technology were not adequate to substantiate the product-specific claim made in the ad. We therefore concluded that the ad was misleading.
The ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) 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 Beauty Pie Ltd not to state the C-Wave Facial LED treatment mask was “clinically proven to reduce wrinkles in 4 weeks” unless they held adequate substantiation to support the claim.
