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Safety of home phototherapy devices

Adverse effects associated with phototherapy include both acute adverse effects and cumulative, dose-related effects that occur with prolonged use. Early adverse effects associated with BB- and NB-UVB phototherapy are typically limited to erythema and drying of the skin, with maximal erythema occurring between 8 and 24 hours following exposure [34]. Blistering represents a severe acute adverse event more commonly associated with exposure to BB-UVB phototherapy compared to NB-UVB, due to the lower erythemogenicity of NB-UVB. Concerns about the possible increased risk of acute adverse events in the home setting has raised questions about the appropriateness and safety of home phototherapy. Side effects of home phototherapy are common with 44 percent of patients reporting adverse effects, but the reported side effects are mild and include erythema (36%), blisters (1%), pruritus (8%), and dryness (1%) [4]. In a comparison to home versus outpatient phototherapy, there was mild erythema in 87 percent of subjects, burning sensation in 56 percent, severe erythema in 36 percent, and blistering in 6 percent, with no difference in incidence of acute adverse events between the two groups [33]. Thus, acute adverse effects appear to be mild and well-tolerated, with severe reactions occurring in low incidence. Late adverse effects result from the cumulative UVB dose, which leads to aesthetic changes, including premature aging (photoaging), wrinkling, and leathery appearance, increased fragility of the skin, and increased risk of photocarginogenesis [33]. Such late adverse effects correlate directly with the total cumulative dose and the incidence of acute adverse events [35, 36, 37]. Data investigating the carcinogenetic risk associated with exposure to BB- versus NB-UVB do not demonstrate a significant difference. Because photocarginogenesis is directly related to the cumulative dose of UV light and to the incidence of acute adverse events, the presumed long-term risk associated with home phototherapy may be similar to that associated with outpatient treatment. Whereas there are good data demonstrating the long-term safety of physician-administered phototherapy, no such data are available for home treatment. However, the existing data demonstrates no differences in acute adverse events or total cumulative ultraviolet dose and there are no data suggesting that home phototherapy is less safe than standard outpatient treatment [33].

Improved technology has allowed for the evolution of safer home phototherapy devices. Innovative safety features in newer units include a key-locked ON/OFF switch to prevent unauthorized use, a built-in controlled prescription timer (CPT), and a failsafe feature that disables the unit in the event of malfunction [38-45]. The controlled prescription timer (CPT) ensures that the equipment can only be used for a certain number of treatments as prescribed by the doctor between office visits. Such innovations make phototherapy safer and more appropriate for home use by allowing greater monitoring for appropriate response to treatment and for incidence of adverse events. Additionally, these features decrease the possibility of unauthorized use or inappropriate use and thus reduce physician and patient worry about potential side-effects, lack of follow up, or abuse [39].

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