Lio, Peter

Abstract Background Topical steroid withdrawal syndrome (TSW) is an adverse event following discontinuation of topical corticosteroids (TCS) and is of growing interest among patients and dermatologists. The absence of well-defined diagnostic criteria and limited insights into the pathomechanisms make diagnosis and future research challenging. Objectives To propose preliminary diagnostic criteria for TSW with the erythemato-oedematous subtype applicable for adult and paediatric populations using a Delphi consensus approach informed by a thorough literature review that summarizes the signs, symptoms and histology of TSW. Methods Eleven clinicians experienced in diagnosing and treating suspected TSW in both children and adults participated in a three-round modified Delphi process. Two rounds of surveys were conducted, with items ranked using a 5-point Likert scale. A predefined consensus threshold of ≥ 75% was established for any one feature to be deemed important. The third round involved a live video conference where the panel reached a consensus on essential diagnostic criteria. Results The panel identified 18 critical diagnostic items, encompassing elements from the patient’s clinical history, signs and symptoms. This includes history of escalating TCS requirement, morphology and distribution differing from primary condition, regional or generalized spontaneous neuropathic pain and severe burning sensation of the skin. Conclusions Differentiating TSW from conditions such as severe atopic dermatitis remains challenging. By emphasizing the common signs and symptoms of TSW, we aim to encourage discussions among healthcare professionals and progress towards the development of a reliable diagnostic tool. An author video to accompany this article is available online.

AbstractAtopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high‐level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for “the Agency's current thinking on a particular subject.” Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices).