PowerPoint Presentation


• The mean Dermatology Life Quality Index (DLQI) improvement from Baseline to
Week 8 was significantly greater for CAL/BDP PAD-cream (6.5 points) compared
to CAL/BDP gel/TS (5.6 points) (p<0.0001) (Figure 3). A DLQI between 0 and 1
(no or little impact of disease on the patient’s life) at Week 8 was obtained by
43.8% in the CAL/BDP PAD-cream group and 34.2% in the CAL/BDP gel/TS
group (p=0.0005).

• CAL/BDP PAD-cream treatment convenience, as measured by the PTCS (Table
2) was higher than for CAL/BDP gel/TS at all studied time points, and significantly
higher for all individual questions at week 8 compared to CAL/BDP gel/TS (Fig. 4).

• CAL/BDP PAD-cream was well tolerated with no adverse drug reactions with a
frequency above 1%.

• Overall, 1271 patients were included in this analysis, 551 patients were in the
CAL/BDP PAD-cream group, 542 patients were in the CAL/BDP gel/TS group, and
178 patients were in the PAD-cream vehicle group. Overall, demographic and
baseline characteristics were comparable between the three treatment groups
(Table 1).

• The proportion of patients achieving PGA treatment success (at least 2-step
improvement to clear or almost clear) at Week 8 was statistically significantly
higher in the CAL/BDP PAD-cream group (43.2%) compared to the CAL/BDP
gel/TS group (31.9%) (p<0.0001). Moreover, a statistically significant difference in
PGA between CAL/BDP PAD-cream and CAL/BDP gel/TS was observed as early
as Week 4 (p=0.0001) (Figure 1).

RESULTS

Linda Stein Gold1, Andreas Pinter2, Matthias Augustin3
1Dermatology Clinical Research, Henry Ford Health System, Detroit, Michigan, USA; 2Dept. of Dermatology, Venereology and Allergology, University Hospital Frankfurt/Main, Frankfurt/Main, Germany; 3University Medical Center Hamburg-Eppendorf, Hamburg, Germany

EFFICACY AND SAFETY OF CALCIPOTRIENE/BETAMETHASONE DIPROPIONATE CREAM 
FOR THE TREATMENT OF PLAQUE PSORIASIS EVALUATED FROM POOLED PHASE 3 DATA

• 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 trials were 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. SD, standard deviation. TS, Topical suspension.

ACKNOWLEDGEMENTS & ABBREVIATIONS

CONCLUSIONS
• In an exploratory post-hoc statistical analysis of the pooled phase 3 data, CAL/BDP

PAD-cream showed significantly greater efficacy than CAL/BDP gel/TS. Patient-
reported outcomes demonstrate that CAL/BDP PAD-cream generally offers greater
patient satisfaction when compared to CAL/BDP gel/TS.

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

investigator-blinded, parallel-group trials (NCT03802344 and NCT03308799)
comparing the efficacy of CAL/BDP PAD-cream with CAL/BDP gel/topical
suspension (TS) and PAD-cream vehicle. Adult patients with mild-moderate
psoriasis according to the Physician Global Assessment (PGA) were enrolled and
applied trial medication once daily for up to 8 weeks.

• The primary endpoint in the US trial (NCT03308799) was the proportion of
subjects who achieved minimum 2-points improvement in PGA to clear or almost
clear disease from Baseline to Week 8. The primary endpoint of the EU trial
(NCT03802344) was the percentage change in modified Psoriasis Area and
Severity Index (mPASI) from Baseline to Week 8.

• The two phase 3 trials each evaluated superiority of CAL/BDP PAD-cream versus
PAD-cream vehicle, and non-inferiority versus CAL/BDP gel/TS.

• The statistical analysis of pooled phase 3 data presented herein was performed as
an exploratory, post-hoc analysis to evaluate statistical differences between
CAL/BDP PAD-cream and CAL/BDP gel/TS based on a modified intention-to-treat
population (n=1271) having at least one assessment of PGA after Baseline.
Multiple imputation for missing data was applied for endpoints, except for Psoriasis
Treatment Convenience Scale (PTCS) for which missing data was imputed using a
Last Observation Carried Forward approach.

Figure 1. PGA Treatment Success

Figure 2. mPASI, percentage change from baseline

• The mean percentage reduction in mPASI from Baseline to Week 8 was
significantly greater for CAL/BDP PAD-cream (64.6%) than CAL/BDP gel/TS
(56.4%) (p<0.0001). The difference in mPASI treatment effect between CAL/BDP
PAD-cream and CAL/BDP gel/TS was statistically significant as early as Week 1
(p=0.0009) (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 DLQI improvement 

2023 Winter Clinical - Miami

*: p<0.05; **: p<0.01; ***: p<0.001; ****: p<0.0001;  CAL/BDP PAD-cream vs. CAL/BDP gel/TS

CAL/BDP PAD-cream
(n=551)

CAL/BDP gel/TS
(n=542)

PAD-cream vehicle
(n=178)

Mean age, years (SD) 50.9 (14.1) 52.2 (14.2) 50.6 (13.8)

Male, n (%) 337 (61.2) 333 (61.4) 113 (63.5)

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

Mean mPASI (SD) 7.5 (3.9) 7.8 (4.0) 7.6 (4.0)

Mean DLQI (SD) 9.6 (6.0) 9.9 (6.7) 9.3 (6.2)

Table 1. Baseline demographics and characteristics

3,6

25,2

37,7

43,2

2,0

15,6

24,6

31,9

0,0
1,5

3,2
5,2

0

10

20

30

40

50

0 2 4 6 8

%
 P

G
A

 tr
ea

tm
en

t s
uc

ce
ss

Weeks

CAL/BDP PAD-cream

CAL/BDP gel/TS

PAD-cream vehicle****

****

****

25,5

52,6

60,5
64,6

20,5

43,6

51,2
56,4

8,5

15,3
19,4 20,0

0

10

20

30

40

50

60

70

0 2 4 6 8

m
PA

SI
, %

 c
ha

ng
e 

fr
om

 b
as

el
in

e

Weeks

CAL/BDP PAD-cream

CAL/BDP gel/TS

PAD-cream vehicle

***

****

****
****

-3,7

-5,7

-6,5

-3,4

-5,0

-5,6

-1,8
-2,1

-2,5

-7

-5

-3

-1

0 2 4 6 8

D
LQ

I i
m

pr
ov

em
en

t

Weeks

***
****

P=0.0575

# PTCS questions

1 How easy was the treatment to apply to the skin?

2 How greasy was the treatment when applying it to the skin?

3 How moisturized did your skin feel after applying the treatment?

4 How greasy did your skin feel after applying the treatment?

5 How much did treating your skin disrupt your daily routine?

6 Overall, how satisfied were you with the medical treatment?

Table 2. PTCS Questions                       Figure 4. PTCS at week 8 

CAL/BDP PAD-cream

CAL/BDP gel/TS

PAD-cream vehicle

0

2

4

6

8

10

#1 #2 #3 #4 #5 #6

PT
CS

Questions

CAL/BDP PAD-cream

CAL/BDP gel/TS

****
********

***

**
*


	Dias nummer 1