Calcipotriene 0.005%–Betamethasone Dipropionate 0.064% Ointment Versus Topical Suspension in the Treatment of Plaque Psoriasis: A Randomized Pilot Study of Patient Preference

Comment

Psoriasis is a chronic disease that can be difficult to treat, and treatment compliance often is poor. Multiple topical agents often are needed for adequate disease control, and adherence can be an even greater hurdle than with monotherapy. Combination products such as calcipotriene–betamethasone dipropionate offer the potential advantage of once-daily application. Adherence to once-daily application regimens for treatment of psoriasis has been shown to be greater than twice-daily application (82% vs 44%).⁴ However, the vehicle may be an adherence barrier for some patients.

Calcipotriene 0.005%–betamethasone dipropionate 0.064% topical suspension originally was indicated for the treatment of psoriasis of the scalp; however, it is now also indicated for treatment of psoriasis of the body.¹² This topical suspension formulation is less messy, which could potentially be more cosmetically appealing and useful for improving treatment adherence.

Overall, the participants in our small pilot study showed a preference for the topical suspension versus the ointment formulation. The difference was substantial but was not statistically significant. This result is consistent with a previous study in which patients were found to prefer solutions that were less greasy compared to messy sticky ointments.¹⁰ Although the topical suspension received a higher average rating from participants for how it felt to touch and how it felt under clothing than the ointment and the ointment was rated on average as more greasy (none of these individual items achieved statistical significance), the calcipotriene–betamethasone dipropionate ointment was still rated as slightly appealing overall (Table 2). This result supports the need for physicians to discuss individual patient preferences when choosing the most appropriate vehicle for topical psoriasis treatment.

In our study, participants were found to use less product during treatment with the topical suspension versus the ointment, likely because the topical suspension formulation is thinner and spreads easier; however, participants rated the ease of application of the 2 products equally (Table 2). Ease of application was rated moderately appealing and time to apply was rated slightly to moderately appealing, which is important because patients often cite these factors as barriers to treatment adherence.^2,6,13

The occlusive properties of ointment formulations provide moisturization by preventing water loss, a property that can be desirable when treating psoriatic plaques. Unlike the ointment, which was formulated with petrolatum and mineral oil, the calcipotriene–betamethasone dipropionate topical suspension was formulated with hydrogenated castor oil and mineral oil to provide moisturization. Nevertheless, participants found both the ointment and topical suspension to be moderately appealing (median score, 6; P=.94) for moisturization.

Limitations of this pilot study include the small sample size, which restricted the extent of subgroup analyses and the generalizability of our results. The small sample size also may or may not have contributed to the lack of statistical significance in the majority of the outcomes. This study provides pilot data that can be used to define a larger study; however, we do not think that a larger study is needed, as patients can be offered both vehicles in a practical clinical setting and can choose the product that is right for them. The short treatment duration of 3 days for each formulation also is a limitation, as a patient’s preference may change over time with longer use of the product. Treatment efficacy, which was not measured in this study, also could have an effect on patient preference, which could be assessed over a longer treatment period. Additionally, the study drugs may not be representative of all ointments or topical suspensions in their cosmetic appeal.

Conclusion

In this small cohort of plaque psoriasis patients, a calcipotriene–betamethasone dipropionate topical suspension was preferred over an ointment formulation, but in clinical practice it may be best to allow patients to choose the vehicle formulation that is most desirable on an individual basis. The topical suspension provides clinicians with an alternative that not only has the benefits of a combination product but also has been found to be appealing to patients.