Journal of Clinical and Aesthetic Dermatology

MAY 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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28 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY May 2018 • Volume 11 • Number 5 O R I G I N A L R E S E A R C H might improve patient adherence. The Psoriasis Process of Care Consensus Panel noted that spray is the preferred vehicle for the scalp, male chest, and other hair-bearing locations, as well as when there is extensive skin involvement. 5 PILOT STUDY METHODS Study design. Twenty patients with plaque psoriasis of the scalp were enrolled in this 16-week study. They used desoximetasone spray 0.25% twice daily for four weeks, followed by twice-daily application on two consecutive days per week for an additional 12 weeks. Subjects also applied the study material to other areas affected by plaque psoriasis, excluding the face, groin, and axillae. Inclusion/exclusion criteria. The main inclusion criteria were men and women aged 18 years or older with a diagnosis of chronic plaque psoriasis of the scalp, with a scalp surface involvement of at least 30 percent and an Investigator Global Assessment (IGA) scale score of at least 2 on a 0- to 4-point scale. Main exclusion criteria were subjects with non-plaque psoriasis (e.g., guttate or pustular); those with less than 30-percent scalp involvement; and those using study-prohibited medications and therapies within 2 to 4 weeks (depending on medication/therapy being used) of baseline. Subjects were permitted to use non-steroidal topical medications on the face, groin, and axillae during the study period. Study endpoints. Efficacy endpoints included IGA scale score of scalp involvement, using a 5-point (0–4) scale that recorded overall disease severity based on average scores for erythema, induration, and scaling of affected areas made at each visit. The IGA scale used was 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. Psoriasis Scalp Severity Index (PSSI) and scalp surface area (SSA) were also calculated. The average degree of scalp erythema, induration, and desquamation severity were assessed and assigned a score of 0 to 4 (0=mild, 4=severe). The SSA was estimated as a percentage. The PSSI score is the sum of the erythema, induration, and desquamation scores multiplied by the SSA. Another efficacy endpoint was Physician Global Assessment (PGA) Scale score, a 5-point scale that records the overall disease severity at each clinical evaluation based on the average degree of erythema, induration, and scaling of all areas affected by psoriasis. The PGA scale used was 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. BSA was determined for all subjects throughout the study. BSA was calculated by using the palm sizes of subjects to represent one percent of BSA. 5 Patient-reported outcomes included subject self-assessments of pain, itching, and scaling of the scalp in the prior 24 hours on a Likert scale of 1 to 10 (1=minimal, 10=severe) at Weeks 0, 4, and 16. In addition, Scalpdex, a self-administered QOL instrument developed for scalp dermatitis, was used. 9 This 23-item survey evaluates patients with cutaneous scalp involvement across the domains of pain, function, and emotion over the preceding three weeks. It was also administered at Weeks 0, 4, and 16. Demographics and baseline characteristics. The intent-to-treat (ITT) population (n=20) was used for analysis. The mean age of the subjects was approximately 50 years. The majority of subjects (75%) were female and Caucasian (80%). Subjects had had scalp psoriasis for a mean of 12.6 years (Table 1). The mean PGA at baseline was 3.1±0.7, the mean BSA was 4.1±2.5, the mean BSA×PGA was 12.7±8.2, the mean scalp IGA was 3.1±0.6, the mean PSSI was 27.3±10.0, and the mean SSA at baseline was 42.3±15.0 (Table 2). Baseline subject reports included a mean baseline pain score of 4.0±2.5, itch score of 7.1±2.7, and a scaling score of 7.0±2.4. The mean baseline Scalpdex score was 65.7±15.0. RESULTS Efficacy results. The response to treatment was rapid across all efficacy parameters. By Week 4, mean PGA had decreased from 3.1±0.7 (moderate disease) to 1.4±1.0 (almost clear). This represents a decrease from a baseline value of 54.8 percent. At Week 16, mean PGA was 1.6±1.3, a decrease of 48.4 percent from baseline. BSA decreased from 4.1±2.5 at baseline to 2.0±2.9 at Week 4 for a decrease of 2.1±1.7 or 51.2 percent. At Week 16, the mean BSA was 3.4±3.7, representing a change from baseline of 0.4±2.9 or 17 percent. BSA×PGA was reduced from 12.7±8.2 to 5.0±11.4, a decrease of 7.4±6.8 (63%) from baseline. By Week 16, the BSA×PGA change from baseline was 3.0±8.9 or 31.5 percent. At Week 4, scalp IGA was reduced by 2.0±0.9 to 1.1±0.7 (i.e., from moderate disease to almost clear). By Week 16, mean scalp IGA was 1.5±1.2, demonstrating a change of 1.6±1.2 from baseline and representing a decrease of 64.5 percent.This improvement was maintained with a change from baseline of 51.6 percent. PSSI was reduced by 82.4 percent at Week 4, with a decrease of 23.6±7.1 from baseline to 4.8±5.2. At Week 16, the change from baseline was 17.0±13.8 (63.4%) (Figure 1). SSA was reduced to 12.4±16.0 percent at Week 4 from 42.3±15.0 percent at baseline, representing a change of 31.0±16.8 percent or 70.7 percent. At Week 16, mean SSA was 24.4±24.4 percent, representing a change of 17.9±28.1 percent or 42.3 percent from baseline. Figure 2 shows the changes in mean subject- reported scores from baseline to the study's end. Patient-reported pain was 1.9±1.8 at Week 4, representing a decrease of 2.1±2.6 (52.5%) from baseline. At Week 16, the mean pain score was 2.4±2.0—a decrease of 40 percent (1.5±2.6) from baseline. Itch was reduced by 62 percent at Week 4 to 2.7±2.0 for a decrease of 4.1±2.5 from baseline. At Week 16, the mean itch score TABLE 1. Study subject demographics (ITT population N=20) AGE Mean ± SD 50.2 ± 18.3 years Median (P25, P75) 48.6 (35.0, 68.6) years Minimum and maximum 25.0 years and 78.9 years SEX Male 5 (25.0%) Female 15 (75.0%) RACE Caucasian 16 (80.0%) Asian 3 (15.0%) Mixed 1 (5.0%) YEARS OF SCALP PSORIASIS Mean ± SD 12.6 ± 10.5 Median (P25, P75) 10.0 (6.0, 18.0) Minimum and maximum 0.3 and 44.0 ITT: intent-to-treat; n; number; SD: standard deviation TABLE 2. Baseline disease characteristics ASSESSMENT SCALE MEAN SCORES PGA 3.1±0.7 (moderate) BSA 4.1±2.5 BSA × PGA 12.7±8.2 Scalp IGA 3.1±0.6 (moderate) PSSI 27.3±10.0 SSA 42.3±15.0% PGA: Physician Global Assessment; BSA: body surface area; IGA: Investigator Global Assessment; PSSI: psoriasis scalp severity index; SSA: scalp surface area

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