Acne scarring: protocol for development of a core outcome set for clinical trials

Introduction
Acne scarring is one of the primary sequelae that affect patients with acne, with facial scarring occurring to some extent in 95% of patients with active acne. Subtypes include atrophic, hypertrophic and keloid scarring. Treatment options include topical and surgical approaches. Despite numerous clinical trials focusing on acne scarring treatments, the absence of standardised outcome reporting across these trials raises concerns in evaluating treatment methods. To address this issue, this project aims to develop a core set of outcomes which should be uniformly assessed in all clinical trials involving acne scarring.

Methods and analysis
Outcomes will be extracted from four sources: a systematic literature review, patient interviews, printed and electronic sources and stakeholder involvement. The steering committee will assess the potential outcomes, adding or removing outcomes if needed. The Delphi process will be performed to understand the importance of outcomes. Two rounds of Delphi surveys will be completed by physicians, researchers and patients. Following this, a consensus meeting involving stakeholders will be held to refine the outcomes based on participant scores. The meeting will end in a voting process to determine a final recommended core outcome set (COS). This study will be conducted in collaboration with the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the CHORD COUSIN Collaboration (C3). This study aims to develop a global COS to standardise assessment approaches in clinical trials of acne scarring. The final goal is to enhance uniformity of outcome reporting.

Ethics and dissemination
Ethical approval and consent to participate for the study have been granted by Northwestern University Institutional Review Board protocol ID: STU00097285. On completion of the COS, we plan to publish our results in peer-reviewed journals and send participants the finalised COS.

PROSPERO registration details
This study is registered with PROSPERO (CRD42023460964), COMET (754) and C3 (https://www.c3outcomes.org/improved-acne-scarring).

Leggi
Aprile 2025

Widening access to isotretinoin in primary care: an evaluation of New Zealand national dispensing data for isotretinoin for acne, 2008-2023

Objectives
To identify what changes in the prescribing of isotretinoin have occurred since funded prescriber access was widened in 2009 from ‘dermatologist only’ prescribing to include ‘general practitioners (GPs) and nurse practitioners working within their scope of practice’.

Design
Evaluation of isotretinoin dispensing data from 2008 to 2023 using the national annual prescribing data obtained from the New Zealand Pharmaceutical National Collection database.

Setting
All New Zealand citizens prescribed and dispensed funded isotretinoin for acne from 2008 to 2023 were included.

Main outcome measures
The prescribing data were analysed to identify the total number of prescriptions per year by prescribing clinician type, patient ethnicity and deprivation levels.

Results
In 2008, nearly 100% (26897) of dispensed prescriptions were written by a dermatologist, while in 2023, 79% (39432) were written by primary care clinicians. Annual isotretinoin prescriptions increased by 87%, from 26 897 (2008) to 50613 (2023). Prescriptions for Māori increased from 1750 in 2008 to 4374 in 2023, with similar increases for other ethnic minorities.

Conclusion
Expanding the prescriber cohort has resulted in a substantial increase in prescriptions, with primary care now issuing the majority of isotretinoin prescriptions. These data demonstrate that the GP workforce can absorb and manage the additional acne workload from the increasing population. Enhanced access for patients suggests an unmet need. An absolute number of prescriptions have risen faster for Māori and Asian patients than for Europeans. Pacific people were generally lower than Europeans. This suggests the longstanding ethnic disparity in access to isotretinoin is partially reduced.
Many countries have restrictions on patient access to isotretinoin, similar to New Zealand in 2008. This is the first study demonstrating that, given appropriate postgraduate education and support, the isotretinoin risk–benefit profile may be enhanced to safely deliver high-quality, timely, equitable patient access to isotretinoin in primary care.

Leggi
Gennaio 2025