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• In Figure 2 comparison of BDP recovery is made by drug deposition retrieved

from individual tape strips representing progressive skin depth through SC and

epidermis.

• Higher amounts of BDP were generally deposited through the skin layers from

CAL/BDP cream compared to TS, and as expected, most drug was deposited in

the upper skin layers (SC) compared to lowers layers (epidermis) after this single

application.

• The study population included 10 healthy female subjects.

• Consistently higher amounts of BDP were deposited in the skin following

CAL/BDP cream application than CAL/BDP TS application at 1 hour, 2 hours, 4

hours, and 8 hours.

• The values in Figure 1 indicate the total BDP recovered from tape strips ( # 3, 5,

7…19) reflecting the total relative amount of drug deposited to SC and epidermis

• Statistical significance was demonstrated in favour of enhanced drug delivery from

CAL/BDP cream over CAL/BDP TS (p ≤ 0.05) at all time points.

• The highest amount of BDP deposited from CAL/BDP cream was present at 1

hour after application with continuing detection at slightly lower levels at hours 2,

4, and 8. BDP deposited from CAL/BDP TS remained lower and consistent at all

time points.

• The B17P metabolite was below the lower limit of quantitation in all tested

samples.

RESULTS

Zoe D. Draelos1, Matthew M. Draelos1, Morten Praestegaard2

1Dermatology Consulting Services, PLLC, High Point, North Carolina; 2MC2 Therapeutics, Hørsholm, Denmark

ENHANCED SKIN DEPOSITION OF BETAMETHASONE DIPROPIONATE INTO THE SKIN OF HUMAN VOLUNTEERS FROM 

CALCIPOTRIENE/BETAMETHASONE DIPROPIONATE CREAM COMPARED TO TOPICAL SUSPENSION

• Calcipotriene (CAL) and betamethasone dipropionate (BDP) cream is an effective

and convenient treatment of plaque psoriasis made possible by PAD

Technology™ 1.

• PAD Technology is a novel innovative topical formulation and drug delivery system

that allows formulation and efficient topical delivery of challenging molecules,

while at the same time maintaining a favourable aesthetic feel of the formulation.

• The delivery of topical psoriasis medications into the skin is very important for

dermatological efficacy. Corticosteroid in combination with calcipotriene is one of

the most effective treatments for psoriasis, yet the drug must enter the skin

efficiently in order for efficacy to be achieved.4 One way to improve clinical results

is to optimize delivery through enhanced vehicles.

INTRODUCTION

CONCLUSION

• CAL/BDP cream is an innovative topical treatment for plaque psoriasis based on

PAD™ Technology.

• CAL/BDP cream delivered more BDP into the upper (SC) and lower layers

(epidermis) of the skin than CAL/BDP TS. This may account for the observed

difference in efficacy in favour of CAL/BDP cream demonstrated in Phase III trials2.

• This study confirms PAD Technology’s benefit in topical delivery in a limited sample

size study.

• As a limitation, this study was small and included only female subjects

OBJECTIVE 

• The objective of the study was to demonstrate the skin deposition of BDP and its

major metabolite betamethasone 17-propionate (B17P), from CAL/BDP Cream

as compared to CAL/BDP Topical Suspension (TS).
Figure 1. ng BDP recovered from tape strips reflecting compound deposited to

stratum corneum and epidermis

1

1 Praestegaard et al. Dermatology & Therapy, 2022. doi: 10.1007/s13555-022-00794-y

2. Pinter A, et al. JEADV. 2022;36(2):228-36. 3. Wynzora® Cream USPI. 4 Stein Gold et al. J Drugs Dermatol. 2021 Apr 1;20(4):420-425.

doi: 10.36849/JDD.2021.5653

REFERENCES

Figure 2. Comparison of recovery of BDP by hours after application from tape 

strips representing progressive skin depth through SC and epidermis.

CAL/BDP cream CAL/BDP TS

METHODS

• 0.1 ml of CAL/BDP cream and CAL/BDP TS were applied once to four one-inch

squares on the forearms of human female volunteers. One one-inch square on

each arm served as control with no product applied.

• At 1 hour, 2 hours, 4 hours, and 8 hours after application, tape strips were applied

to the application site and held in place for 10 seconds. The first two tape strips

removed were discarded to avoid confounding the analysis with residual cream on

the skin. This procedure was repeated 20 times on the same area to allow

sampling of the stratum corneum (SC) and epidermis down to the level where

punctate bleeding occurred indicating intrusion into the dermis. The control square

was processed only at 1 hour after application

• Liquid chromatography–mass spectrometry (LCMS) was used to determine the

amount of BDP and the metabolite B17P present. Only the odd-numbered tape

strips (# 3, 5, 7…19) were analyzed while the even-numbered tape strips (#4, 6,

8…20) were saved as backups.

• A t-test was used to analyze the paired data with statistical significance defined as

p≤0.05.

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CAL/BDP Cream CAL/BDP TS

Stars denote a statistical significant difference between CAL/BDP cream and TS:

*:p<0.05; **: p<0.01; ****:p<0.0001