ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics; Ortho Dermatologics is a division of Bausch Health US, LLC | Presented at Winter Clinical Dermatology Conference 2020 • January 17-22, 2020 • Kohala Coast, HI

SYNPOSIS

 ◾ In the treatment of dermatologic disease, formulation characteristics drive efficient 
topical delivery and patient acceptance, with patients preferring less oily/sticky 
formulations (eg, foams, lotions)1

 ◾ Recently, a new lotion formulation that allows for simultaneous deposition of active 
ingredients and excipients on the skin surface was developed to be well‑liked by 
patients, improve adherence, and normalize epidermal barrier function2

 ◾ This formulation—utilizing polymeric emulsion technology—is used to deliver 
lower‑dose dermatologic products

• Two for psoriasis: a combination halobetasol propionate 0.01%/tazarotene 0.045%  
(HP/TAZ; Duobrii®) and HP 0.01% (Bryhali®) 

• One for acne: tazarotene 0.045% (in development)

 ◾ Upon contact with salts on the skin, the polymeric matrix (3‑D mesh) dissolves, allowing 
for uniform absorption of active ingredients and hydrating excipients (Figure 1)

OBJECTIVE

 ◾ To summarize properties of a unique vehicle lotion formulation and permeation of active 
drug of the HP/TAZ and HP lotion formulations

METHODS

 ◾ Skin hydration and epidermal barrier maintenance with the vehicle lotion were assessed 
through corneometry and transepidermal water loss (TEWL; N=30)

 ◾ Patient preference to several features of the vehicle lotion were assessed through a 
questionnaire (18 questions) administered to 15 participants

 ◾ Percutaneous permeation studies were used to evaluate in vitro dermal deposition of:

• HP/TAZ lotion vs HP 0.05% cream (Ultravate) and TAZ 0.1% cream (Tazorac) individually

• HP 0.01% lotion vs 0.05% cream

RESULTS

Polymeric Emulsion Technology Formulation
 ◾ With polymeric emulsion technology, the active ingredient and moisturizing/hydrating 
ingredients are encapsulated within oil droplets (Figure 1A)

• Oil droplets are uniformly dispersed within an oil‑in‑water emulsion separated by a 3‑D 
mesh matrix 

• Additional water‑soluble moisturizing excipients are trapped within the 3‑D matrix

 ◾ Once applied to the skin, the mesh instantly breaks apart, ensuring rapid, uniform, and 
simultaneous release of ingredients (Figure 1B and C)

 ◾ This technology has the potential to overcome several limitations of conventional topical 
drug delivery, including limited skin delivery and local cutaneous irritation2

Vehicle Lotion: Epidermal Barrier Function and Patient Preference
 ◾ The vehicle lotion formulation provided rapid and sustained increases in skin 
moisturization (Figure 2) and gradual decreases in TEWL (Figure 3) over 24 hours 

 ◾ Most participants (93%‑100%) responded favorably (strongly agree or agree) to 
questions asked about attributes of the vehicle lotion (hydrating, moisturizing, skin 
absorption, aesthetic), such as: 

• Skin does not feel greasy; Skin feels refreshed; Skin feels immediately soft and smooth; 
Skin feels lasting hydration; Skin feels more moisturized and hydrated than with what I 
currently use

• Product absorbs quickly; Product absorbs quicker than what I currently use; Product 
provides lightweight moisturization

Novel Lotion Formulation Using Polymeric Emulsion Technology for Improved Skin Moisturization and Drug 
Permeation in Patients With Psoriasis

Emil A Tanghetti, MD1; Linda Stein Gold, MD2; James Q Del Rosso, DO3; Stefan Weiss, MD4; Tina Lin, PharmD5; Arturo Angel, BS6; Radhakrishnan Pillai, PhD6
1Center for Dermatology and Laser Surgery, Sacramento, CA; 2Henry Ford Hospital, Detroit, MI; 3JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 4Direct Dermatology, Palo Alto, CA; 5Ortho Dermatologics,* Bridgewater, NJ; 6Bausch Health US, LLC,* Petaluma, CA
*Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

FIGURE 3. Skin Barrier Assessment Using Transepidermal Water Loss (TEWL; N=30)

0

2

4

6

8

10

12

14

16

0 hours 0.25 hours 0.5 hours 1 hour 2 hours 3 hours 8 hours 24 hours

M
e
a
n
 S

co
re

s 
±

 S
D

 

Vehicle Lotion
Untreated Control

***P<0.001 vs untreated control. SD, standard deviation.

Percutaneous Absorption of HP/TAZ and HP 
 ◾ Higher HP permeation efficiency was seen with 0.01% lotion than 0.05% cream 
(Figure 4)

 ◾ Similarly, HP/TAZ lotion demonstrated higher cutaneous permeation efficiency of active 
ingredients into the dermal layers than HP 0.05% cream or TAZ 0.1% cream alone 
(Figure 5)

• The advantage of the HP 0.01%/TAZ 0.045% lotion formulation was further 
demonstrated when it was shown that simply layering TAZ 0.1% cream onto HP 0.05% 
cream decreased the cutaneous permeation of tazarotene2

FIGURE 4. Dermal Levels Following 24 Hours of Topical Exposure to 
Halobetasol 0.01% Lotion vs Halobetasol 0.05% Cream (N=10)

6.17%

1.72%

0.91%

0.28%

1.97%

1.34%

0%

1%

2%

3%

4%

5%

6%

7%

8%

Receptor Dermis Epidermis

P
e
rc

e
n
t 

o
f 

A
p

p
lie

d
 D

o
se

 (
M

e
a
n
) HP 0.01% Lotion

Halobetasol 0.05% Cream

HP, halobetasol propionate.

FIGURE 2. Skin Moisturization Assessment Using Corneometry (N=30)

0

10

20

30

40

50

60

70

0 hours 0.25 hours 0.5 hours 1 hour 2 hours 3 hours 8 hours 24 hours

M
e
a
n
 S

co
re

s 
±

 S
D

 

Vehicle Lotion
Untreated Control

***P<0.001 vs untreated control. SD, standard deviation.

FIGURE 1. Novel Approach to Topical Lotion Formulation: Polymeric Emulsion Technology

A. Uniform Distribution C. Absorption of Active Ingredient(s) and
Excipients

B. Mesh Dissolves

3-D mesh dissolves instantly upon contact with salts on skin
Active ingredient(s)

and moisturizing/hydrating
agents uniformly
absorbed by skin

1-2 μm

3-D mesh allows for uniform distribution of
active ingredient(s) and moisturizing agents

Droplets consisting of active ingredient(s) and
oil soluble moisturizing agents held apart
by the 3-D mesh

25-50 μm       

3-D Mesh (polymeric matrix)
holding water and water soluble hydrating
agents within the mesh

FIGURE 5. Dermal Levels Following 24 Hours of Topical Exposure to Halobetasol/
Tazarotene Lotion vs Halobetasol 0.05% Cream (A) or Tazarotene 0.1% Cream (B)

0.48%

1.37%

4.97%

0.28%

1.34%

1.72%

0%

1%

2%

3%

4%

5%

6%

P
e
rc

e
n
t 

o
f 

A
p

p
lie

d
 D

o
se

 (
M

e
a
n
)

0.004%

2.8%

18.0%

0.002%

1.5%

10.8%

0%

5%

10%

15%

20%

Receptor Dermis EpidermisReceptor Dermis Epidermis

A. Halobetasol Dermal Levels (N=10) B. Tazarotene Dermal Levels (N=10)

HP 0.01%/TAZ 0.045% Lotion
Halobetasol 0.05% Cream

HP 0.01%/TAZ 0.09% Lotion
Tazarotene 0.1% Cream

HP, halobetasol propionate; TAZ, tazarotene.

CONCLUSIONS
 ◾ Lotion formulations for the treatment of psoriasis and acne have been 
developed that utilize an innovative polymeric emulsion technology and 
an optimal selection of solvents, emollients, and humectants

 ◾ The vehicle lotion formulation is non‑greasy, aesthetically pleasing, and 
provides enhanced barrier to the skin

 ◾ Further, application of the lower‑dose HP/TAZ and HP lotion formulations 
resulted in higher permeation efficiency of the active ingredients 
compared with application of HP or TAZ cream alone

 ◾ These results suggest that this unique lotion formulation may provide a 
more effective, predictable, and patient‑preferred treatment option than 
cream formulations

REFERENCES
1. Svendsen et al. J Dermatolog Treat. 2019:1‑6.
2. Tanghetti et al. J Dermatolog Treat. 2019:1‑8.

AUTHOR DISCLOSURES
Dr. Emil Tanghetti has served as speaker for Novartis, Ortho Dermatologics, Sun, Lilly, Galderma, AbbVie, and Dermira; 
served as a consultant/clinical studies for Hologic, Ortho Dermatologics, and Galderma; and is a stockholder for 
Accure. Dr. Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO, 
Dermavant, Incyte, Novartis, AbbVie, and Lilly. Dr. James Del Rosso has served as a consultant, investigator, and 
speaker for Ortho Dermatologics. Dr. Stefan Weiss has served as consultant, speaker, advisor or research honoraria 
from AbbVie, Ortho Dermatologics, Jansen Biotech, Dermira, Almirall, Brickell Biotech, DermTech, and Scynexis. 
Dr. Tina Lin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company. 
Mr. Arturo Angel and Dr. Radhakrishnan Pillai are employees of Bausch Heal US, LLC and may hold stock and/or stock 
options in its parent company.