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Structured pregnancy prevention programmes enable safe isotretinoin therapy in young women, achieving zero pregnancies with complete contraceptive adherence in real-world practice.
According to the outcomes of a real-world study from Poland, isotretinoin therapy for moderate-to-severe acne can be safely administered to adolescent and young adult women under structured pregnancy prevention programme (PPP) protocols, with no pregnancies reported during treatment.
Isotretinoin is a highly valuable systemic therapy but carries a substantial teratogenic risk, making strict pregnancy prevention essential. To address this, the European PPP mandates standardized counselling, contraception, and monitoring, although real-world compliance data have been limited. This retrospective analysis included 569 female patients aged 14–25 years treated with isotretinoin in Poland between 2021 and 2022. Patients were categorized based on PPP adherence into full, partial, and minimal compliance groups.
Outcomes assessed incorporated contraceptive use, cumulative dosing, adverse events, laboratory monitoring, and treatment discontinuation, with statistical significance set at p < 0.05. No pregnancies occurred across any compliance group, and all patients reported contraception use or abstinence. Condoms were the most common method (92.79%), followed by abstinence (7.21%) and oral contraceptives (1.93%).
Cumulative isotretinoin dosing differed markedly by PPP compliance (Kruskal–Wallis H = 19.89), with fully compliant patients receiving lower mean cumulative doses than those with partial or minimal adherence. Treatment discontinuation occurred in 4.75% of patients, exclusively among fully compliant individuals. These patients received markedly lower cumulative doses than those who completed therapy (Mann–Whitney Z = 7.81), suggesting that closer monitoring facilitated earlier identification of adverse effects or patient concerns.
An inverse connection between age and cumulative dose was also noted (H = 13.09), with younger patients (≤17 years) more likely to achieve therapeutic dose targets. Overall, the findings confirm that structured PPP implementation ensures safe and effective isotretinoin therapy, achieving complete contraceptive adherence and preventing pregnancy in real-world practice. The observed differences in dosing and discontinuation patterns highlight the importance of flexible, patient-centred approaches to optimize outcomes while maintaining safety.
Journal of Clinical Medicine
Compliance with the European Pregnancy Prevention Programme in Isotretinoin Treatment: Safety Outcomes and Dose-Related Correlations
Piotr Brzeziński et al.
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