Patient Preference for Calcipotriene 0.005%/Betamethasone Dipropionate 
0.064% Foam or Topical Suspension vs. Latest Topical Treatment in the 

PSO-INSIGHTFUL Study
Jennifer Soung, MD,1 Lisa Tiu, PharmD,2 Karen Veverka, PhD,2 Chih-Ho Hong, MD3

1Southern California Dermatology; 2LEO Pharma Inc; 3University of British Columbia, Department of Dermatology and Skin Science and Probity Medical Research 

Introduction

Results

Conclusions
Materials & Methods

Acknowledgements

References

� Topical therapies are a mainstay in psoriasis vulgaris 
treatment and are used in combination therapy even in 
patients receiving systemic or biologic therapy

� Patient preference for vehicle formulation can impact 
adherence and, consequently, real-life effectiveness

� The PSO-INSIGHTFUL study was designed to assess 
patient-reported factors that influence preference 
following once-daily topical treatment with calcipotriene 
0.005%/betamethasone dipropionate 0.064% (Cal/BD) 
foam and gel1

� Questionnaires (including Topical Product Usability 
Questionnaire, TPUQ; Comparison to Latest Topical 
Treatment, CLTT) were completed by patients at 
baseline and timepoints during the study to assess 
usability and preference differences

PSO-INSIGHTFUL Study Design

� PSO-INSIGHTFUL was a prospective, multicenter, 
Phase IIIb, open-label, randomized, two-arm crossover 
study including patients ≥18 years with mild-to-severe 
psoriasis of ≥6 months’ duration involving 2-30% BSA 
and mPASI of ≥2 (Table 1)

� After 4-week washout, 213 patients were randomized 
1:1 to once-daily Cal/BD foam for 1 week, followed by 
Cal/BD gel for 1 week, or vice-versa (Figure 1)

Figure 1: Schematic of study design of PSO-INSIGHTFUL, [NCT02310646] 2

Study Assessments
� Patients completed questionnaires to assess therapy 

usability and preference differences

o Topical Product Usability Questionnaire (TPUQ)
o Comparison to Latest Topical Treatment (CLTT)

All patients
n = 212 (%)

Age category, n (%)
18 – 39 years 48 (22.6)
40 – 59 years 92 (43.4)
≥ 60 years 72 (34.0)

Male : Female, n (%) 133:79 (63:37)
BMI, n (%)

< 25 kg/m2 37 (17.5)
25 – 30 kg/m2 73 (34.4)
> 30 kg/m2 102 (48.1)

PGA, n (%)
Mild 61 (28.8)
Moderate 122 (57.5)
Severe 29 (13.7)

Duration of psoriasis, n (%)
< 2 years 4 (1.9)
2 – 5 years 30 (14.2)
> 5 years 178 (84.0)

BSA, n (%)
< 4% 93 (43.9)
4 – 6% 56 (26.4)
6 – 11% 38 (17.9)
11 – 15% 11 (5.2)
≥ 15% 14 (6.6)

mPASI, n (%)
2 – 5 86 (40.6)
5.1 – 10 91 (42.9)
> 10 35 (16.5)

Mean DLQI 7.8
Localized:widespread distribution of psoriasis, % 62:38

Table 1. Patient Demographics and baseline characteristics 
(adapted from PSO-INSIGHTFUL)

BMI, body mass index; BSA, body surface area; mPASI, modified psoriasis and severity index; PGA,
Physician’s Global Assessment of disease severity

� Full analysis set comprised all randomized patients 
who completed an on-study questionnaire

� LTT analysis set comprised all randomized patients 
who had used topical treatment within 3 months 
before baseline

Statistical Analysis

Topical Product Usability 
Questionnaire (TPUQ) 
� Each patient assessed the extent to which they 

agreed with each of the 26 items using 5-point 
scale (-2 to 2), organized into four domains: 
“application”, “formulation”, “container”, 
“satisfaction,” regarding product usability.

� Frequency:
o Following randomization, the TPUQ was used to 

assess the LTT at baseline
o During visits to the clinic at the end of weeks 1 

and 2, patients completed TPUQ based on their 
treatment experience during the previous 7 days

Comparison to Latest Topical 
Treatment (CLTT) 
� Patients stated whether they preferred their LTT or 

Cal/BD foam/gel, or had no preference

� Frequency:
o During visits to the clinic at the end of weeks 1 

and 2, patients completed CLTT based on their 
treatment experience during the previous 7 days

� Overall, patients from the PSO-INSIGHTFUL study 
had stronger preferences for either Cal/BD foam or 
gel as compared to their last topical treatment

� These results from the Topical Product Usability 
Questionnaire are further corroborated with the 
similar results in the Comparison to Latest Topical 
Treatment survey

� The significant differences observed in favor of 
Cal/BD foam as compared to the topical suspension 
formulation are related mainly to application and a 
“feeling of relief” which may be attributable to the 
vehicle

� These data provide insight into aspects of topical 
product usability, but more robust research is 
necessary to obtain a complete understanding

LTT 
(n=118)

Cal/BD 
foam 

(n=116)

Cal/BD 
topical 

suspension 
(n=115)

Application domain scores
Ease of application 1.4 1.2 1.5
Ease of application on lesion only 1.3 0.9* 1.4
Ease of spreading 1.5 1.5 1.7*
Lack of mess 0.6 0.9 1.0**
Good for use on small areas 1.1 1.0 1.4*
Good for use on large areas 0.9 1.4*** 1.5***
Quick to apply 1.2 1.5** 1.3
Total time spent acceptable 1.1 1.6*** 1.4**
Easily incorporated into daily routine 1.0 1.5*** 1.4***

Formulation domain scores
Quickly absorbed 0.2 0.7** 0.6**
Dried quickly 0 0.5** 0.4**
Immediate feeling of relief 0.1 1.1*** 0.7***
Felt soothing 0.6 1.3*** 1.0**
Appealing to touch 0.2 1.0*** 0.9***
Felt moisturizing 0.6 1.3*** 1.2***
Not greasy –0.5 0.2*** 0.2***
Odourless 1.2 1.3 1.5**
No staining 0.4 0.9** 0.9***

Container domain scores
Easy to get medication out of container 1.3 1.2 1.3

Easy to use 1.3 1.2 1.4
Easy to keep clean 1.1 1.3 1.3

Accurately dispense wanted amount 1.0 0.9 1.5***

Satisfaction domain scores
Confidence in using 0.6 1.3*** 1.2***
Would use regularly 0.9 1.4** 1.3*
Would recommend 0.4 1.3*** 1.0***

Overall satisfaction 0.3 1.2*** 1.1***

Table 2. Mean TPUQ scores compared with LLT, by domain, 
for Cal/BD foam and topical suspension

Range: –2, strongly disagree to +2, strongly agree
*P<0.05; **P<0.01; ***P<0.001 vs LTT. LTT included various corticosteroids (of different potencies) and
combination products, with similar types of products in all categories (ointment, cream, ‘other’)

Cal/BD foam or Cal/BD topical suspension vs. LTT:  

� Mean TPUQ domain scores were often significantly in 
favor of both Cal/BD foam and topical suspension 
compared with LTT

� Scores for Cal/BD topical suspension were generally 
higher than for LTT

� Most scores for Cal/BD foam were higher, although some 
related to ease of application and container items were 
comparable to LTT

Cal/BD foam vs. Cal/BD topical suspension:

� Mean application, container and satisfaction domain 
scores were high for both Cal/BD foam and gel

� Both Cal/BD foam and Cal/BD gel had very high 
application domain scores for:
o Good for use on large areas
o Total time spent acceptable
o Quick to apply
o Easily incorporated into daily routine

� Significant differences observed in favor of Cal/BD foam 
vs topical suspension in the domains of “immediate 
feeling of relief” and “soothing feeling”

� Significant differences observed in favor of Cal/BD topical 
suspension vs foam included:
o Ease of application, ease of application on lesion only, and ease of spreading
o Good for use on small areas
o Odorless
o Accurately dispensed wanted amount

Cal/BD 
foam 

(n=212)

Cal/BD 
topical 

suspension 
(n=212)

P value

Application domain scores
Ease of application 1.1 1.5 **
Ease of application on lesion only 0.9 1.4 ***
Ease of spreading 1.5 1.7 **
Lack of mess 0.8 1.0 NS
Good for use on small areas 1.0 1.4 ***
Good for use on large areas 1.4 1.5 NS
Quick to apply 1.4 1.4 NS
Total time spent acceptable 1.5 1.5 NS
Easily incorporated into daily routine 1.4 1.5 NS

Formulation domain scores
Quickly absorbed 0.7 0.7 NS
Dried quickly 0.5 0.5 NS
Immediate feeling of relief 1.0 0.7 **
Felt soothing 1.2 1.0 **
Appealing to touch 0.9 0.9 NS
Felt moisturizing 1.1 1.2 NS
Not greasy 0 0.3 *
Odourless 1.3 1.6 ***
No staining 1.0 1.0 NS

Container domain scores
Easy to get medication out of container 1.1 1.3 NS

Easy to use 1.1 1.4 ***
Easy to keep clean 1.2 1.4 *

Accurately dispense wanted amount 0.9 1.5 ***

Satisfaction domain scores
Confidence in using 1.2 1.2 NS
Would use regularly 1.3 1.3 NS
Would recommend 1.2 1.1 NS

Overall satisfaction 1.1 1.2 NS
Range: –2, strongly disagree to +2, strongly agree
*P<0.05; **P<0.01; ***P<0.001

Table 3. Mean TPUQ scores, by domain, for Cal/BD foam and 
topical suspension

Poster presented at the Fall Clinical Dermatology Conference, Las Vegas, NV; October 12th – 15th, 2017

All patients; foam-gel*

Localized (n = 128) 0.5 ± 8.8

Widespread (n = 78) -2.1 ± 8.2

All patients (n = 204) -0.5 ± 8.2

*Negative difference indicates preference for gel

Table 4. Difference in total formulation score (TPUQ) between study treatments 
by psoriasis distribution phenotype (FAS)

Differences in TPUQ scores between study treatments by 
psoriasis distribution

� The forward selection procedure identified psoriasis distribution as 
a significant factor

� Trend towards more favorable scores for Cal/BD foam in patients 
with localized distribution and in favor of gel for patients with 
widespread distribution

1 Hong C-H, Papp KA, Lophaven KW, et  al. Patients with psoriasis have different preferences 
for topical therapy, highlighting the importance of individualized treatment approaches: 
Randomized Phase IIIb PSO-INSIGHTFUL study [submitted].

2 ClinicalTrials.gov.  Bethesda (MD):  National Library of Medicine (US). 2017 Jun 1. Identifier: 
NCT02310646. Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel 
in Subjects With Psoriasis Vulgaris. 
https://clinicaltrials.gov/ct2/show/NCT02310646?term=NCT02310646&rank=1

This study was sponsored by LEO Pharma; Editorial support was 
provided by Dharm Patel, PhD at LEO Pharma Inc. US.  


	FC17PosterLEOSoungPatientPreference.pdf