Background: Hidradenitis suppurativa (HS) is an inflammatory disease of the inverse skin regions that occurs in young women, in particular, and affects approximately 1% of the population. Outpatient care is often inadequate and usually cannot prevent progression., Objectives: To evaluate in the EsmAiL ('Evaluation eines strukturierten und leitlinienbasierten multmodalen Versorgungskonzepts für Menschen mit Akne inversa') trial whether an innovative care concept can decrease disease activity and burden, and improve patient satisfaction., Methods: EsmAiL was conducted as a two-arm, multicentre, prospective, randomized controlled trial that included 553 adults with HS. Inclusion criteria were a minimum of three inflammatory lesions and at least a moderate impact of the disease on quality of life. The control group (CG) remained under standard care, while patients in the intervention group (IG) were treated according to a trial-specific, multimodal concept. The primary endpoint was the absolute change in International Hidradenitis Suppurativa Severity Score System (IHS4)., Results: In total, 274 patients were randomized to the IG and 279 to the CG. Altogether, 377 attended the final assessment after 12 months of intervention. Participants in the IG (n = 203) achieved a mean improvement in IHS4 of 9.3 points, while the average decrease in IHS4 in patients in the CG (n = 174) was 5.7 points (P = 0.003). Patients treated under the new care concept also reported a statistically significantly higher decrease in pain, Dermatology Life Quality Index and Hospital Anxiety and Depression Scale scores compared with those in the CG (P < 0.001). Patient satisfaction was also statistically significantly higher in the IG compared with the CG (P < 0.001)., Conclusions: The establishment of standardized treatment algorithms in so-called 'acne inversa centres' in the ambulatory setting has a substantial, positive impact on the course of HS and significantly improves patient satisfaction., Competing Interests: Conflicts of interest M.S. reports auditor activity on the implementation of the contract ‘AOK-Priomed Acne inversa’ for LENICURA; the receipt of honoraria for lectures from AbbVie; and the funding of travel, congress and hotel fees from AbbVie and Pfizer. P.S. has received grants or contracts from Novartis and Almirall; consulting fees from AbbVie, Allergika, Almirall-Hermal, Amgen, Beiersdorf, Biocryst, BMS, Boehringer Ingelheim, Celgene, CSL Behring, Eli Lilly, Falk, Galderma, Hexal, Janssen, Klinge, Klosterfrau, LEO Pharma, LETI Pharma, L’Oréal, Novartis, Octapharma, Pfizer, Pflüger, Pharming, Regeneron, Shire, Takeda, Sanofi–Genzyme and UCB Pharma; and has had a leadership or fiduciary role for the Society of dermopharmazie, unrelated to work presented here. G.N. reports consulting fees from Dessau Medical Center, which received a consulting fee from Mölnlycke Health Care GmbH, for which he served as a consulting physician; has received speaker fees for attending the European Academy of Dermatology and Venerology (EADV) hidradenitis suppurativa course held on 28–30 November 2022 in Porto, Portugal; and has received an Eli Lilly scholarship for attending the EADV Congress 2021. F.B. has received consulting fees from AbbVie, Incyte, AbbVie Deutschland, MoonLake, Novartis Pharma, Janssen Cilag and UCB Pharma; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events for AbbVie, Incyte, AbbVie Deutschland, Novartis Pharma, Janssen Cilag and UCB Pharma; support for attending meetings and/or travel from AbbVie, Incyte, AbbVie Deutschland, Novartis Pharma, Janssen Cilag and UCB Pharma; and has participated on a data protection monitoring board or advisory board for AbbVie, Incyte, AbbVie Deutschland, Novartis Pharma, Janssen Cilag, UCB Pharma and Boehringer Ingelheim Pharma. U.K. has received consulting fees from Novartis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Novartis; has participated on a data protection monitoring board or advisory board for Novartis, EsmAiL and EpiCAi; and has had a leadership or fiduciary role for Deutsche Gesellschaft für Wundheilung und Wundbehandlung. K.H. has patents planned, issued or pending (DE102015000150B4); and has stocks or stock options in LENICURA (CEO and stockholder of the company). M.G. has received grants or contracts for clinical studies on hidradenitis suppurativa as deputy Principal Investigator (PI) sponsored by Novartis, Janssen and UCB, and for clinical studies on pemphigus vulgaris and bullous pemphigoid as PI sponsored by Argenx, and for a clinical study on prurigo nodularis as PI sponsored by Galderma (institutional contract; no personal payment); consulting fees from Almirall (personal payment) and Argenx (payment to institution); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from GSK, Eli Lilly and Janssen (personal payment); support for attending meetings and/or travel from UCB (travel support); has participated in data protection monitoring or advisory boards for UCB, GSK and LEO (personal payment); and is a member of the Board of Directors and Treasurer of the German Society of Dermatology (‘Deutsche Dermatologische Gesellschaft’), Section Editor of the Journal der Dt. Dermatologischen Gesellschaft and a member of the Board of Directors of the University Hospital Würzburg (all unpaid). S.G. reports grants or contracts from Novartis and Pierre Fabre; consulting fees from AbbVie, BMS, MSD, Genzyme, Klinge Pharma, Sun Pharma, Kyowa-Kirin, Novartis and Pierre Fabre; has participated on a data safety monitoring or advisory board for Alcedis; and is a member of DeCOG (German dermatological cooperative oncology group), unrelated to the work presented herein., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.)