# lAight® Therapy for Acne Inversa: What IPL Plus Radiofrequency Can and Cannot Do Canonical URL: https://www.acneinversa.life/en/blog/laight-therapy-ipl-radiofrequency-hidradenitis-suppurativa/ Markdown URL: https://www.acneinversa.life/en/blog/laight-therapy-ipl-radiofrequency-hidradenitis-suppurativa.md Plain text URL: https://www.acneinversa.life/en/blog/laight-therapy-ipl-radiofrequency-hidradenitis-suppurativa.txt Language: en Category: Treatments Published: 2026-07-25 Last updated: 2026-07-25 Last editorially reviewed: 2026-07-25 Next scheduled review: 2027-01-25 Evidence strength: Moderate evidence — Backed by consistent observational studies or smaller trials. Author: Dr. rer. nat. Dennis Alexander Kwiatkowski (Biochemist, Scientific Writer and Pharma Expert) Scientific editor: Dr. rer. nat. Dennis Alexander Kwiatkowski Reviewer qualifications: Biochemist, Scientific Writer and Pharma Expert Review scope: Scientific literature, clinical guidelines, sources, and editorial clarity Clinical reviewer: No independent clinical review Tags: Acne Inversa, Hidradenitis Suppurativa, HS, Treatments, Acne inversa, Hidradenitis suppurativa, lAight, IPL, Radiofrequency, Device therapy, G-BA, IQWiG, Coverage > Since April 2026, the combination of IPL and radiofrequency has been a statutory health insurance benefit in Germany for mild to moderate acne inversa. This article sets out the evidence, the guidelines and the real reimbursement status. Medical disclaimer: This website is for general educational information only and does not replace medical advice, diagnosis, or treatment. Please speak with qualified medical professionals about symptoms or treatment decisions. ## Article > **For information only.** This article summarises the publicly documented > state of knowledge about a medical device. It is not a treatment > recommendation and does not replace medical advice. Whether a therapy is > right for you is a decision to make together with your dermatologist. Last updated: 25 July 2026. For most people with acne inversa (medically: hidradenitis suppurativa), the treatment plan has looked much the same for years: antiseptics and topical antibiotics in mild disease, systemic antibiotics and biologics in moderate to severe disease, surgery for permanently damaged tissue. lAight® therapy sits outside that pattern – it is not a drug but a device that combines intense pulsed light (IPL) with radiofrequency (RF). Since 9 April 2026, this method has in principle been a statutory health insurance benefit in Germany. That is a notable development, and it raises the obvious questions: how well supported is it? Who is it for? And can I simply go and get it now? The short answers are: moderately well, for a narrower group than the marketing suggests, and – as of today – not yet. This article explains why. ## The key points at a glance - **There is one genuine, good trial.** The RELIEVE study with 88 participants is a randomised controlled trial with a low risk of bias. That is more than many device-based therapies in acne inversa can show. - **The proof of benefit is narrowly cut.** It applies to Hurley stage I and II, as an *add-on* to topical clindamycin, and essentially for a single endpoint: response in disease severity. - **Pain and quality of life remained unresolved.** Both effects were numerically measurable but did not clearly survive the test for clinical relevance. - **IQWiG reached an "indication", not "proof".** That is the middle of four certainty tiers – defensible, but not settled. - **The safety picture is favourable.** Transient warmth, redness, itching; the assessment bodies found no serious adverse events. - **Covered in principle, not billable in practice.** The G-BA decision has been in force since April 2026, but without an EBM fee code a practice cannot yet bill a statutory insurer. That is expected in autumn 2026. - **The evidence comes largely from one environment.** Most of the research originates in Mainz and the manufacturer's provider network, with disclosed ties. That is not an accusation, but it is a reason for caution. ## What is lAight® therapy? lAight® is a medical device from LENICURA GmbH in Wiesbaden, developed since 2011 together with the dermatology department of Universitätsmedizin Mainz. The device combines two physical principles in one session. The skin is first moistened with a contact gel. Then follow **three passes**, each with a different light filter and each combined with radiofrequency. The light is broad-spectrum but explicitly excludes UV-A and UV-B. The proposed explanation of how this works runs as follows: - **Blue light** is absorbed in the uppermost skin layer, said to reduce hyperkeratosis and to act as a bactericide. - **Green and yellow light** is absorbed at the level of the sebaceous glands and said to reduce sebaceous gland activity and TNF-α exposure. - **Red light** is absorbed at the hair root and said to have an anti-inflammatory effect. - **Radiofrequency** penetrates the dermis via hair follicles and fistula openings, flows through the fluid trapped in the abscess or sinus tract, and is said to thermally denature collagen at the margins of the inflammatory focus – which in turn is said to stimulate new collagen formation and the activity of capillaries and lymphatic vessels. One clarification matters here, because it tends to disappear in promotional material: **this is a hypothesis, not a demonstrated fact.** The G-BA puts it plainly – the precise mechanism of action of the therapy has not yet been conclusively clarified. The German S2k guideline says the same. The description above is, in the documents' own words, "an attempt to explain the working principle". Basic mechanistic studies are missing. This is not disqualifying – the precise mechanism is not fully understood for plenty of established therapies either. But it means the assessment rests entirely on what clinical trials produced. A plausible-sounding mechanism cannot fill gaps in the data. ### What a course of treatment looks like The pivotal trial used **eight sessions two weeks apart over 16 weeks**. The G-BA adopted exactly that schedule as the ceiling for one treatment cycle. Further cycles are permitted if the previous one produced a response. Published device parameters are sparse. The most explicit public figures come from the US study of 2022: IPL at 420–1200 nm with 4.4–6.0 J/cm² in four sub-pulses, radiofrequency at 1 MHz with 12.2 J/cm². These figures are a reasonable guide but do not necessarily match every German protocol variant. ## What the evidence actually shows This is where it pays to look closely – because with this method, the gap between "there are studies" and "it is proven" is the whole story. ### The one load-bearing trial: RELIEVE **RELIEVE, Period A** (Schultheis et al., *Dermatology* 2022) is the pivotal trial. Multicentre, randomised, run in Germany and Poland, 88 participants – 45 in the intervention group, 43 in the control group. Over 16 weeks, one group received IPL+RF in addition to topical clindamycin 1%, the other received the clindamycin alone. The result on the primary response measure: **61.5% responders versus 33.3%**, measured by IHS4-55 (an improvement of at least 55% in the severity score). In IQWiG's recalculation this corresponds to an odds ratio of 3.20 (95% confidence interval 1.27 to 8.09; p = 0.015). That is a real finding. The assessor rating disease severity was blinded – with a device therapy, where patient and staff necessarily know what is happening, that is the most important safeguard available. IQWiG rated the overall risk of bias as low. And then come the limitations: - **The COVID-19 pandemic disrupted data collection**, affecting the intervention group more than the control group. - **On pain** (numerical rating scale) the difference was −1.40 points (95% CI −2.78 to −0.02). Statistically significant, but the standardised effect (Hedges' g −0.45; 95% CI −0.89 to 0.00) reached the threshold below which an effect counts as clinically irrelevant. IQWiG classified this as **"no signal"** of benefit. - **On quality of life** (DLQI) the difference was −3.00 points (95% CI −5.43 to −0.57). Again statistically significant, again not robust enough for the relevance test. - **On anxiety and depression** (HADS) there was no significant difference. - **Surgical interventions** – one of the endpoints that matters most to patients – were not recorded in the trial at all. IQWiG was therefore unable to assess this point. A word on how to read the pain result, because it is easily misunderstood: it does **not** mean the therapy fails to relieve pain. It means the available data are insufficient to demonstrate a perceptible pain benefit. Those are different statements. **RELIEVE, Period B** continued the trial from week 16 to 32, with both groups now receiving IPL+RF. Maintenance of remission was reported. IQWiG **did not use** this phase for the benefit assessment – only its safety data – because there was no longer a concurrent control group after week 16. Whether maintenance therapy works in the long run is therefore explicitly an open question. ### What the other studies contribute – and what they do not **The NICE study** (Wilden et al. 2021, 47 participants) was an exploratory Mainz trial with three arms: IPL+RF versus IPL alone versus RF alone. At 12 weeks, the number of active lesions fell more under the combination than under IPL alone (p = 0.044). Against RF alone, however, there was **no significant difference**, and on quality of life there was no significant advantage over either control. There was no placebo arm and no untreated arm. **The US study** (Lyons et al. 2022) is the only investigation outside the German-speaking world – and the only one that also included advanced disease (Hurley II–III). Ten patients were treated in a split-body design: one side of the body treated, the other not. The result was a 2.8-point improvement in DLQI (p = 0.043), but **no improvement on a single clinical endpoint** – not HSPGA, not HiSCR, not IHS4. The study is small, but its design is elegant because each person serves as their own control. On the question "does it help in severe disease too?", it is the clearest evidence we have – and the answer, on these data, is no. **The provider registry** (Strobel et al. 2024) is by far the largest dataset, covering 3,437 people, and reports "satisfying disease control in all stages". Large numbers are misleading here, though: these are uncontrolled data from the manufacturer network's documentation software, with no comparator and considerable scope for selection effects. People who stop a therapy because it is not helping systematically show up less often in analyses of this kind. **The EsmAiL trial** deserves its own paragraph, because it is the most frequently miscited. With 553 participants it is the largest randomised trial in this space, and its results are impressive: the IHS4 score improved by 9.3 versus 5.7 points (p = 0.003), along with steeper falls in pain, DLQI and HADS. It won the Hufeland Prize 2023 and the MSD Health Prize 2024. But EsmAiL **did not test the device.** It tested a complete care concept – an "acne inversa centre" with patient education, structured wound care, defined treatment pathways *and* lAight® as one component among several – against standard care. The measured effect cannot be attributed to any single component. Where a source cites EsmAiL as evidence of lAight® efficacy, that is a methodological error. Tellingly, the successor project **EsmeDerm** transfers precisely this *centre concept* to psoriasis and atopic dermatitis – not the device. ### What the assessment bodies made of it Two independent German institutions examined the evidence and reached the same conclusion. The **Medical Service of the federal associations (MD Bund)** found in January 2024 an "indication" of benefit in Hurley I–II, driven essentially by the differences in disease severity and treatment response. For quality of life, pain, depression and anxiety it found no evidence of benefit or harm once clinical relevance was taken into account. **IQWiG** published its final report in January 2025. It identified exactly **one** usable randomised trial – RELIEVE – and concluded, across endpoints, that there was an "indication of greater benefit" for Hurley I–II. The word "indication" (*Hinweis*) is a technical term with a fixed meaning. IQWiG uses four tiers of certainty: | Tier | Meaning | |---|---| | **Proof** (*Nachweis*) | high certainty | | **Indication** (*Hinweis*) | moderate certainty ← *IPL+RF sits here* | | **Hint** (*Anhaltspunkt*) | low certainty | | No hint / no signal | no conclusion possible | So IPL+RF reaches the **middle** tier – and only for the disease-severity and response endpoint, only in Hurley I–II, only as an add-on to topical clindamycin. When promotional material turns this into "scientifically proven", that is not a translation but an upgrade by one tier. ## What the guidelines say The **German S2k guideline** of 2024 contains two recommendations on IPL+RF: 1. A **combination of IPL+RF and topical clindamycin** should be recommended as an alternative to topical clindamycin monotherapy in mild and moderate disease. Consensus strength: **"consensus"** (over 75% agreement). 2. **IPL+RF monotherapy as maintenance therapy** should be recommended. Consensus strength: only **"majority agreement"** (50–75%). That second figure is revealing. "Majority agreement" is the weakest tier at which a recommendation still passes – meaning up to one in two members of the guideline group did not agree. Within the expert panel there was visible disagreement about maintenance therapy. The guideline runs to April 2029; no revision is currently under way. Internationally the picture is more reserved. The **European S2k guideline** of 2025 builds its treatment algorithm around medical and surgical therapy and does not give IPL+RF a comparably specific maintenance recommendation. The **British Association of Dermatologists** guideline and the **North American guidelines** address laser and light modalities in general terms (chiefly Nd:YAG and CO₂ lasers); IPL+RF is not a focus there. In the United States there is **no FDA clearance** for this indication; the device is offered only in Germany and Austria. That divergence is worth noting: the national guideline, which involved authors from the trial environment, recommends the method considerably more strongly than the European one. ## Cost and coverage: where things stand For patients this is often the most pressing question – and the answer changed fundamentally in 2026, but has not yet arrived. **How it used to work.** The therapy was for a long time a self-pay service (IGeL, or billed privately under the GOÄ schedule). Anyone wanting coverage had to submit an individual case application. Two insurers broke ranks early: **AOK Hessen** became the first statutory fund to cover it from 1 April 2021 through a selective contract, and **AOK Bayern** followed in October 2022. **What changed.** On **22 January 2026** the Federal Joint Committee decided to add IPL in combination with radiofrequency to the Methods Directive for outpatient care – for adults with Hurley stage I–II, as an add-on to topical antibiotics, a maximum of eight sessions within 16 weeks, with documentation and training requirements. The decision entered into force on **9 April 2026**. **What is still missing.** A G-BA decision establishes *that* a service may be provided. It does not establish *how it gets paid for*. For that, the Valuation Committee must create a fee code (GOP) in the uniform value scale (EBM). It has six months to do so – so until roughly October 2026. **As of 25 July 2026 that fee code has not been published.** The notices from the National Association of Statutory Health Insurance Physicians and the EBM change trackers through the 1 July 2026 update contain no such code. In practical terms: the service has been approved but cannot yet be billed to a statutory insurer. It is expected "from autumn 2026". So if a practice offers you the treatment today, ask explicitly: are you already billing my insurer, or would I be paying myself? For Austria, no comparable development is known; there, delivery continues through the private provider network. ## Who is behind it – and why that matters for the assessment This section is not an accusation. The relationships described here are **disclosed** in the relevant publications – which is exactly how scientific transparency is supposed to work. But knowing about them is part of reading the evidence. - **The research is heavily concentrated in one centre.** RELIEVE, NICE and EsmAiL were all led from Universitätsmedizin Mainz, which co-developed the therapy with the manufacturer. - **The manufacturer supported the study sites.** Devices, training, infrastructure and contact gel were provided free of charge to the trial network; the publications state that implementation of the questionnaire in the LENICURA software was also provided free of charge. Practices receive the documentation software at no cost – which also explains why the registry data come from precisely that network. - **Even the "independent" US study is not entirely independent.** Its first author reported having served as a sub-investigator for LENICURA. Notably, it is that very study which came out negative on clinical endpoints. - **Authorship overlaps with the guideline.** A co-author of RELIEVE and EsmAiL is also an author of the S2k guideline chapter on device-based therapies. - **Patient organisations carry manufacturer-supported content.** At NIK e.V., the relevant pages are explicitly marked "with the kind support of: LENICURA" – so the sponsorship is disclosed. - **The German Wikipedia article** adopts the manufacturer's framing, such as "the only therapy option approved for all severity levels", and leans heavily on manufacturer-linked sources. It is not a neutral reference here. Why this matters: not because it makes the results wrong – a blinded endpoint assessor is still a blinded endpoint assessor. Rather because **replication by an independent team is missing**, and replication is what turns an "indication" into "proof". That step has not yet been taken. ## Who is this realistically for? **Most likely worth considering** if you: - have mild to moderate disease (Hurley I or II), - are using or can use topical clindamycin and are looking for something to add to it, - prefer a non-pharmacological option, or want to avoid or cannot tolerate systemic therapies, - have access to a practice in the provider network, and - hold realistic expectations about the size of the effect. **Probably not the right option** if you: - have severe disease (Hurley III) – there is no positive efficacy evidence for it, and the only study including advanced cases was negative, - have one of the contraindications (see the FAQ), - are looking primarily for pain relief – the least well-supported endpoint, - expect an alternative to biologics or surgery in advanced disease, or - would currently have to pay out of pocket and need that money more urgently elsewhere. One further, entirely practical point: eight appointments in 16 weeks is a substantial commitment of time and travel. That belongs honestly in the calculation. ## What would change the picture Four developments would shift the assessment in this article: 1. **Publication of the EBM fee code.** It changes nothing about the evidence, but everything about actual access. Expected in autumn 2026. 2. **A genuinely independent randomised trial** – no Mainz involvement, no provider network, no manufacturer interest – that reproduces the benefit. That would be the step from "indication" to "proof". 3. **Data on hard endpoints**: surgeries avoided, long-term remission with a real comparator beyond 16 weeks. Both are entirely absent. 4. **An updated guideline** that strengthens or weakens the recommendation – in particular, whether maintenance therapy attracts more than a narrow majority next time. ## Conclusion lAight® therapy is neither the breakthrough it is marketed as nor something disreputable. It is a plausible, well-tolerated add-on option with a decent but narrow evidence base – recognised by two German assessment institutions, recommended by the national guideline, a statutory benefit in principle since 2026, and yet resting on a single informative trial from a tightly networked research environment. For people with Hurley I or II looking for something to add to topical therapy, it is a defensible thing to try – particularly once the insurer pays. For everyone else, the honest answer is that the data do not yet support it. If you are considering the therapy, these are the questions to ask at the practice: which Hurley stage am I in? Are you already billing my insurer? What exactly would we measure after eight sessions to decide whether it worked? And what is the plan if it did not? ## FAQ ### Will my health insurer pay for this now? Not yet in practice. The Federal Joint Committee (G-BA) decided on 22 January 2026 that IPL+RF becomes a statutory benefit, and the decision entered into force on 9 April 2026. But before a practice can actually bill a statutory insurer, the Valuation Committee must first create a fee code in the EBM fee schedule. As of 25 July 2026 that had not happened; it is expected in autumn 2026. Ask your practice directly whether they can already bill your insurer or whether you would be paying yourself. ### Which disease severity is the therapy actually supported for? Solid data exist only for mild to moderate disease, meaning Hurley stage I and II, and there only as an add-on to topical clindamycin. IQWiG, the Medical Service of the federal associations and the G-BA all explicitly restricted their positive assessments to Hurley I–II. The only study that also included Hurley III found no improvement in clinical outcomes. ### Why do some sources say the therapy is approved "for all severity levels"? Because the device's CE mark does cover all severity levels. But a CE mark is not a certificate of efficacy: it says a product may be placed on the market, not that it has been shown to help at every severity. That distinction is frequently blurred in promotional material. ### Does it help with pain? That remains open. In the pivotal trial the difference in pain was statistically significant, but IQWiG could not establish with confidence that it was large enough to matter to patients – the confidence interval extended into the range considered clinically irrelevant. This does not mean the therapy fails to relieve pain. It means the available data cannot demonstrate that benefit. ### What does a course of treatment involve? In the pivotal trial it was eight sessions two weeks apart over 16 weeks. That is exactly what the G-BA set as the ceiling for one cycle: a maximum of eight sessions within 16 weeks. Further cycles are permitted if the previous cycle produced a response and further improvement is expected. A session consists of three passes with different light filters, each combined with radiofrequency, applied over a contact gel. ### What are the side effects and contraindications? The safety profile is considered favourable. Reported effects are mainly transient warmth and redness of the treated areas, usually resolving within 24 hours, plus increased itching and pigment changes. Very rarely, superficial skin damage such as burns or blisters occurred. Contraindications include pregnancy, epilepsy, electronically controlled implants such as pacemakers, marked photosensitivity, skin cancer, and tattoos, piercings or permanent make-up at the treatment sites. Importantly, combining IPL with resorcinol or systemic tetracyclines may increase the risk of adverse events. ### Who is allowed to deliver the treatment? The diagnosis must be made by a dermatologist. The G-BA opened delivery more widely: alongside dermatology, also gynaecology and obstetrics, urology, plastic/reconstructive and aesthetic surgery, general surgery, general medicine, internal medicine and paediatrics. Documentation and training requirements are part of the decision. ### Does IPL+RF replace a biologic or surgery? No. The guidelines position the therapy as an add-on and a maintenance option in mild to moderate disease, not as a substitute for systemic therapy in moderate to severe disease or for surgical removal of irreversibly damaged tissue. In advanced disease, biologics and surgery remain the mainstays. ## References 1. S2k guideline on the treatment of hidradenitis suppurativa / acne inversa (AWMF register 013-012) - AWMF, 2024 - https://register.awmf.org/assets/guidelines/013-012l_S2k_Therapie-Hidradenitis-suppurativa-Acne-inversa_2024-08.pdf 2. Final report N24-01: IPL therapy in combination with radiofrequency for hidradenitis suppurativa / acne inversa - IQWiG, 29 January 2025 - https://doi.org/10.60584/N24-01 3. Decision 7662 amending the Methods Directive for outpatient care: IPL in combination with radiofrequency for acne inversa - Gemeinsamer Bundesausschuss, 22 January 2026 (in force 9 April 2026) 4. Schultheis M et al. LAight® Therapy Significantly Enhances Treatment Efficacy of 16 Weeks of Topical Clindamycin Solution in Hurley I and II Hidradenitis Suppurativa (RELIEVE, Period A). Dermatology, 2022. 5. Wilden S et al. Combined treatment of hidradenitis suppurativa with intense pulsed light (IPL) and radiofrequency (RF). Journal of Dermatological Treatment, 2021. - https://pubmed.ncbi.nlm.nih.gov/31609667/ 6. Lyons AB et al. Preliminary Assessment of a Combination Intense Pulsed Light and Radiofrequency Device in Hidradenitis Suppurativa. Journal of Drugs in Dermatology, 2022. - https://pubmed.ncbi.nlm.nih.gov/35389583/ 7. Schultheis M et al. Effectiveness of a multimodal care concept for patients with hidradenitis suppurativa (EsmAiL). British Journal of Dermatology, 2023. - https://pubmed.ncbi.nlm.nih.gov/37132470/ 8. Nilforoushzadeh MA et al. Efficacy and safety of radiofrequency in the treatment of hidradenitis suppurativa: a systematic review. Lasers in Medical Science, 2024. - https://pubmed.ncbi.nlm.nih.gov/38795173/ 9. Strobel L et al. Real-world data on the treatment of hidradenitis suppurativa with LAight therapy. Journal der Deutschen Dermatologischen Gesellschaft, 2024. 10. Zouboulis CC et al. European S2k guidelines for hidradenitis suppurativa / acne inversa, part 2. Journal of the European Academy of Dermatology and Venereology, 2025.