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• Also at week 4, the proportion of patients achieving PGA treatment success was
higher in the CAL/BDP PAD-cream group (25.2%) compared to the vehicle group
(0.6%) and numerically higher than the CAL/BDP TS/gel group (18.7%; p=0.0510)
(Figure 2).

• The patient reported PTCS score for CAL/BDP PAD-cream was rated superior to
CAL/BDP TS/gel at week 8 (p<0.0001) and was also significantly higher at week 4
(p<0.0001), demonstrating that CAL/BDP PAD-cream has superior treatment
convenience compared to CAL/BDP TS/gel.

• The mean change in Dermatology Life Quality Index (DLQI) score from baseline
to week 8 improved statistically significantly more in the CAL/BDP PAD-cream
group compared to both vehicle (p<0.0001) and CAL/BDP TS/gel (p=0.0110)
(Figure 3). A statistically significant difference was also observed at week 4 for
CAL/BDP PAD-cream compared to vehicle (p<0.0001) and CAL/BDP TS/gel
(p=0.0159) (Figure 3).

• Safety assessments during the trial demonstrated that CAL/BDP PAD-cream was
well-tolerated with all adverse reactions reported at a frequency below 1%.

• Overall, 490 patients were randomised, 213 patients were in the CAL/BDP PAD-
cream group, 209 patients were in the CAL/BDP TS/gel group, and 68 patients
were in the cream vehicle group. Overall, all demographic characteristics were
comparable between the three treatment groups (Table 1).

• The percentage mean change from baseline to week 8 in mPASI for CAL/BDP
PAD-cream (67.5%) was superior compared to vehicle (11.7%; p<0.0001) and
non-inferior to CAL/BDP TS/gel (63.5%) (Figure 1).

RESULTS

Linda Stein Gold1, Andreas Pinter2, April Armstrong3, Lars Iversen4, Morten Praestegaard4, Matthias Augustin5
1Dermatology Clinical Research, Henry Ford Health System, Detroit, Michigan, USA; 2Dept. of Dermatology, Venereology and Allergology, University Hospital Frankfurt/Main, Frankfurt/Main, Germany; 3Keck School of Medicine, Department of Dermatology, University of Southern California Los Angeles, USA;

4MC2 Therapeutics, Hørsholm, Denmark; 5University Medical Center Hamburg-Eppendorf, Hamburg, Germany

PHASE 3 TRIAL DEMONSTRATING HIGH EFFICACY, FAVOURABLE SAFETY, AND CONVENIENCE OF 
A NOVEL CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE CREAM

• The fixed dose combination of calcipotriene (CAL 0.005% w/w, 50 µg/g) and
betamethasone dipropionate (BDP 0.064% w/w, 0.5 mg/g - as betamethasone) is
a well-established treatment option for psoriasis based on strong scientific
rationale for the single agents having complementary efficacy and safety.

• CAL/BDP PAD-cream is an easily spreadable cream based on PAD Technology™,
an innovative formulation and drug delivery system1.

INTRODUCTION

• Writing support was provided by Anja Snel-Prentø, MedLink.
• The trial was funded by MC2 Therapeutics.
• PGA, Physician Global Assessment. mPASI, modified Psoriasis Area and Severity Index. DLQI, Dermatology Life Quality Index. BDP, betamethasone

dipropionate. CAL, calcipotriene. PTCS, Psoriasis Treatment Convenience Scale. *comparison of CAL/BDP PAD-cream to vehicle. **comparison of
CAL/BDP PAD-cream to CAL/BDP TS/gel.

ACKNOWLEDGEMENTS & ABBREVIATIONS

CONCLUSIONS
• CAL/BDP PAD-cream, an innovative topical treatment for plaque psoriasis based on

PAD Technology, offers high efficacy combined with a favourable safety profile and
a superior patient reported treatment convenience compared to CAL/BDP TS/gel.

METHODS
• CAL/BDP PAD-cream was evaluated in a Phase 3, multicentre, randomized,

investigator-blind, active, and vehicle-controlled trial (NCT03802344) enrolling 490
adult patients with mild to moderate psoriasis according to the Physician Global
Assessment (PGA) scale.

• The aim of the trial was to evaluate the efficacy and safety of CAL/BDP PAD-
cream as well as treatment acceptability compared to cream vehicle and to
CAL/BDP Topical Suspension (TS)/gel (sourced in the EU as Dovobet®/Daivobet®
gel).

• Patients applied trial medication once daily for up to 8 weeks.

• The trial was conducted at 32 clinical sites across three European countries.

• Primary endpoint was percentage change in modified Psoriasis Area and Severity
Index (mPASI) from baseline to week 8.

• Except for Psoriasis Treatment Convenience Scale (PTCS), the endpoints were
analysed using the treatment-policy estimand for the full analysis set. As per
protocol, the percentage change in mPASI from baseline to week 8 for CAL/BDP
PAD-cream and the active comparator were first compared with cream vehicle for
a superiority evaluation. Also per protocol, CAL/BDP PAD-cream was next
compared to active comparator for a non-inferiority evaluation. Secondary
endpoints were tested in a predefined testing hierarchy. Multiple imputation for
missing data was applied for endpoints, except for PTCS for which missing data
was imputed using a Last Observation Carried Forward approach.

Figure 1. mPASI, percentage change from baseline

Figure 2. PGA Treatment Success

• At week 4, CAL/BDP PAD-cream demonstrated statistically significantly greater
mean percentage change from baseline in mPASI compared to vehicle
(p<0.0001) and to CAL/BDP TS/gel (p=0.0006) (Figure 1).

• The proportion of patients achieving PGA treatment success (2-step
improvement to clear or almost clear) after 8 weeks was significantly greater for
CAL/BDP PAD-cream (50.7%) compared to vehicle (6.1%, p<0.0001) and
CAL/BDP TS/gel (42.7%, p=0.0442) (Figure 2).

1Praestegaard M, Steele F, Crutchley N. Polyaphron dispersion technology, a novel topical formulation and delivery system combining drug penetration,
local tolerability and convenience of application. Dermatol Ther (Heidelb). 2022 Oct;12(10):2217-2231.

REFERENCES

Figure 3. Mean change in DLQI  

2023 Winter Clinical Dermatology Conference

25,7

54,6
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No subjects with PGA success were observed at Week 4 in the vehicle group. For this reason, statistical analysis of the difference between CAL/BDP PAD-cream and 
vehicle was inconclusive due to wide 95% Confidence Intervals, although substantial differentiation is demonstrated by the separation.

A negative change from Baseline indicates a decrease in DLQI , i.e., an improvement in the patient’s quality of life.

CAL/BDP Cream
(n=213)

CAL/BDP TS/gel
(n=209)

Cream Vehicle
(n=68)

Mean age, years (SD) 48.6 (13.7) 51.5 (14.8) 50.8 (13.3)

Male, n (%) 136 (63.8%) 113 (54.1) 46 (67.6)

Mean PGA (SD) 2.8 (0.4) 2.8 (0.4) 2.8 (0.5)

Mean mPASI (SD) 7.9 (4.0) 8.0 (3.8) 8.3 (3.8)

Mean DLQI 9.8 9.5 10.0

Table 1. Baseline demographics and characteristics


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