Clinical Topics & News
Reviewing the Medication List With Psoriasis Patients
Dr. Weinberg emphasizes the importance of taking the medication history when evaluating psoriasis patients.
Psoriasis is a chronic relapsing inflammatory skin and joint disease that affects 1% to 3% of the US population.1 In cases of mild to moderate disease, topical agents including corticosteroids, vitamin D analogues, and retinoids are the mainstay of therapy. The need for long-term treatment can be frustrating for patients and treatment adherence often is problematic, resulting in poor outcomes. Reported adherence rates to topical psoriasis treatments range from 27% to 73%.2-6
Topical agents for treatment of psoriasis are available in various formulations, including creams, lotions, gels, ointments, solutions, and shampoos. For topical psoriasis therapies, vehicle formulation plays a major role in both delivery of the active drug and treatment adherence. Patients often cite poor cosmetic characteristics (eg, product feels too sticky or greasy, product feels unpleasant/has a bad texture, product is too messy, product application is too time consuming/takes too long to rub in) as reasons for poor treatment adherence.2,6-9 Psoriasis patients tend to prefer formulations that are not as messy such as solutions and foams versus creams, gels, and ointments.10
Ointments have been favored by physicians for the treatment of psoriasis because of the belief that their occlusive properties result in greater potency; however, a systematic review of clinical trials of different formulations of clobetasol propionate did not find that ointments were more effective than other vehicles.11 Furthermore, if a patient finds an ointment to be cosmetically unacceptable, he/she will be less inclined to use the medication as prescribed, regardless of its potency.
The objective of this study was to conduct a preliminary assessment of patient preference for ointment versus topical suspension formulations of calcipotriene 0.005%–betamethasone dipropionate 0.064% for treatment of plaque psoriasis. The specific attributes that were found to be appealing or unappealing by participants for each formulation also were evaluated.
Methods
Study Design and Participants
This open-label, investigator-blinded, crossover, prospective, single-center study evaluated patient preference for ointment versus topical suspension formulations of calcipo-triene 0.005%–betamethasone dipropionate 0.064% in the treatment of plaque psoriasis. The study protocol was approved by the Wake Forest School of Medicine (Winston-Salem, North Carolina) institutional review board.
Participants were recruited from the Wake Forest School of Medicine dermatology clinic. Inclusion criteria included men and women with mild to moderate plaque-type psoriasis who were 18 years of age or older; participants also were required to have an investigator global assessment (IGA) score of 2 (mild) or 3 (moderate) on a 5-point scale and 1% to 10% body surface involvement on the trunk or extremities.
Exclusion criteria included use of a topical or systemic psoriasis treatment within 2 or 4 weeks of baseline, respectively. Women who were pregnant, breastfeeding, planning to become pregnant, or could potentially become pregnant and were not using a medically accepted form of contraception also were excluded from the study. Patients with other serious skin conditions or any other chronic medical conditions that were not well controlled also were considered ineligible.
As a pilot study, a sample size of 20 participants was needed based on available funding.
Assessments
At baseline, the diagnosis of plaque-type psoriasis in each participant was confirmed by the investigator. Each participant’s medical history was obtained and all prior and current medications were reviewed to ensure eligibility criteria were met. Female participants of childbearing potential also underwent a urine pregnancy test. Consent was obtained from all enrolled participants. Investigators assessed the severity of psoriasis at baseline using the IGA.
All participants then were randomized (1:1 randomization) for treatment with either calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment or calcipotriene 0.005%–betamethasone dipropionate 0.064% topical suspension. A simple random sampling chart was prepared and used by the study staff to determine treatment group allotment. Participants were instructed to apply the assigned study drug to affected areas of the body, excluding the scalp, face, and intertriginous areas, once daily for 3 days. Participants and study staff were aware of the study product being used, while investigators remained blinded. Participants also were asked to maintain a daily medication diary noting when the medication was applied.
Participants returned on day 3 for crossover treatment. Participants were asked to complete a subjective participant preference survey and study staff reviewed concomitant medications and adverse events. The packaging for the initial study drug was collected and weighed, and the crossover drug was dispensed to each participant to be applied once daily for 3 days.
Participants returned on day 6 or 7 for follow-up and were again asked to complete the subjective participant preference survey; study staff reviewed concomitant medications and adverse events. The packaging for the crossover study drug was collected and weighed, and the participant’s medication diary also was collected.
Subjective Participant Preference Survey
The subjective participant preference survey consisted of 15 questions relating to the participant’s experience with the study drug (eg, how the product felt to touch, amount of greasiness, time it took to apply). The final survey question asked participants to rate the overall appeal of the vehicle. Participants responded to the questions using a 7-point grading scale (1=extremely unappealing; 4=neutral; 7=extremely appealing). Total preference scores could range from 15 to 105.
End Points
The primary end point was the mean total preference score for each study drug obtained from the subjective participant preference surveys. Secondary end points included median values for individual survey questions and treatment adherence, which was measured from self-reported medication diary entries.