Limited · human
This Austrian real-world study examined afamelanotide treatment outcomes in 20 patients with erythropoietic protoporphyria (EPP), a rare genetic disorder causing severe phototoxic reactions upon light exposure. Researchers compared pre- and post-treatment data on quality of life (QoL), phototoxic burn tolerance time (PBTT), UV index, and the incidence and severity of phototoxic reactions for the year 2023. The study found that the EPP-specific QoL score increased markedly, with the median rising from 11.11 to 79.17 under therapy. PBTT also improved substantially, increasing from a median of 15 minutes before treatment to 250 minutes during treatment. The proportion of patients experiencing phototoxic reactions fell from 88% at baseline to 33% on therapy. Reported side effects were described as only mild and transient. The authors concluded that these findings support the effectiveness and safety of afamelanotide in EPP. Limitations include the small sample size (n=20), the non-randomized, uncontrolled observational design, and the potential for recall or reporting bias inherent to real-world cohort studies.
Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · Mar 2026DOI ↗ Limited · human
This prospective qualitative study surveyed 104 consecutive patients attending a pigmented lesion clinic at a tertiary referral dermatology centre in Ireland to examine the characteristics, attitudes, and behaviours of sunbed users. Using an anonymous self-reported questionnaire, researchers collected data on demographics, frequency of sunbed use, motivations, and use of unregulated tan-enhancing agents such as Melanotan I and II. The study found that sunbed users were predominantly younger women living in urban areas, consistent with prior literature. Regulatory non-compliance was widespread: over half of sunbed premises reportedly did not provide protective goggles, and nearly half offered no health risk information to customers. Key motivations for use included improving appearance and self-confidence. Notably, greater awareness of health risks did not correlate with reduced sunbed use, suggesting a potentially compulsive or addictive behavioural pattern. Users of tan-enhancing agents also used sunbeds more frequently than non-users. The authors suggest psychological interventions such as cognitive behavioural therapy may be beneficial and call for stricter regulatory enforcement. Limitations include the single-centre design, small sample size, self-reported data susceptible to bias, and a clinic-based population that may not represent the general public.
Skin health and disease · May 2025DOI ↗ Limited · human
This German post-authorisation safety study (PASS; EUPAS13004) evaluated the real-world safety and clinical effectiveness of afamelanotide 16 mg (SCENESSE) in 200 patients with erythropoietic protoporphyria (EPP), a rare inherited disorder causing severe acute phototoxicity upon light exposure. As an ongoing observational study linked to the European EPP Disease Registry, it collected treatment-emergent adverse events as the primary safety variable and used the validated EPP-Quality of Life (EPP-QoL) tool alongside treatment continuity as effectiveness measures. The study found that afamelanotide's real-world safety and benefit-risk profile was consistent with that observed in prior clinical trials. Patients reported a statistically significant improvement in quality of life compared to baseline (p-value not fully quoted in the abstract). High treatment continuity was also noted, suggesting ongoing clinical benefit. Key limitations include the absence of an untreated comparator group within this cohort, the observational (non-randomised) design, and potential for selection bias inherent in registry-based studies. The authors concluded that afamelanotide demonstrated a positive safety profile and was associated with improved quality of life in EPP patients under real-world conditions.
Photodermatology, photoimmunology & photomedicine · Mar 2025DOI ↗