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 • January 17-22, 2020 • Kohala Coast, HI

SYNOPSIS

 ◾ Psoriasis is a chronic, immune‑mediated disease that can have frequent exacerbations 
and remissions1

 ◾ Disease characteristics and optimal treatment strategies for psoriasis may differ 
between males and females2

 ◾ Females may have an increased burden of disease compared with males, as they have 
been shown to have higher levels of stress, stigmatization, and loneliness due to 
psoriasis3

 ◾ Recent phase 3 clinical data demonstrated the efficacy and tolerability of a fixed 
combination lotion containing halobetasol propionate 0.01% and tazarotene 0.045% 
(HP/TAZ; Duobrii® Ortho Dermatologics, Bridgewater, NJ) in patients with 
moderate‑to‑severe localized plaque psoriasis4,5

OBJECTIVE

 ◾ To evaluate efficacy and safety of HP/TAZ lotion in female and male patients with 
moderate‑to‑severe plaque psoriasis

METHODS

 ◾ In two phase 3, multicenter, double‑blind studies, participants were randomized (2:1) 
to receive HP/TAZ or vehicle lotion once‑daily for 8 weeks, with a 4‑week 
posttreatment follow‑up4,5

• At baseline, patients were required to have an Investigator Global Assessment (IGA) 
score of 3 or 4 (5‑point scale; 0=clear and 4=severe) and affected Body Surface 
Area (BSA) of 3% to 12% 

• In these studies, CeraVe® hydrating cleanser and CeraVe® moisturizing lotion 
(L’Oreal, NY) were provided as needed for optimal moisturization/cleaning of the skin

 ◾ Data from these two studies were pooled and analyzed post hoc in female and male 
participants

 ◾ Efficacy assessments included treatment success (≥2‑grade improvement from 
baseline in the IGA score and score of ‘clear’ or ‘almost clear’ [primary endpoint]), 
impact on individual signs of psoriasis at the target lesion, and change in BSA 
affected

 ◾ Treatment‑emergent adverse events (TEAEs) were evaluated 

Safety and Efficacy of a Fixed Combination Halobetasol Propionate 0.01%/Tazarotene 0.045% (HP/TAZ) Lotion in 
the Treatment of Females With Moderate‑to‑Severe Plaque Psoriasis

Linda Stein Gold, MD1; Boni Elewski, MD2; Zoe Draelos, MD3; Tina Lin, PharmD4
1Henry Ford Hospital, Detroit, MI; 2University of Alabama at Birmingham School of Medicine, Birmingham, AL; 3Dermatology Consulting Services, PLLC, High Point, NC; 4Ortho Dermatologics*, Bridgewater, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC.

RESULTS

 ◾ The analysis population included 146 female participants (HP/TAZ lotion, n=101; 
vehicle, n=45) and 272 male participants (HP/TAZ lotion, n=175; vehicle, n=97)

Efficacy

 ◾ At week 8, the percentage of female and male participants with treatment success 
was significantly greater in the HP/TAZ group than the vehicle group; significant 
differences were observed by week 2 and maintained posttreatment (Figure 1)

 ◾ Significantly more HP/TAZ‑treated female and male participants achieved a ≥2‑grade 
improvement in erythema, plaque elevation, and scaling at week 8 compared with 
the vehicle group (Figure 2)

 ◾ Females and males treated with HP/TAZ lotion had a significantly greater reduction 
from baseline in affected BSA at week 8 versus the vehicle group, with significant 
differences observed as early as week 4 for females and week 2 for males; significant 
differences were sustained posttreatment for both females and males (Figure 3)

Safety

 ◾ The most frequently reported treatment‑related TEAEs in the female HP/TAZ group 
were contact dermatitis, pruritis, and application site pain (all 4.0%); pruritis was the 
most common TEAE deemed related to vehicle treatment (7.0%)

 ◾ For males in the HP/TAZ group, the most frequently reported treatment‑related TEAE 
was contact dermatitis (7.6%); in the vehicle group, no TEAEs deemed related to 
treatment occurred in >1 male

CONCLUSIONS
 ◾ Halobetasol propionate 0.01% and tazarotene 0.045% lotion was associated with 
significant reductions in disease severity in female as well as male patients with 
moderate‑to‑severe psoriasis, with good tolerability and safety over 8 weeks of 
once‑daily use

REFERENCES
1. Nestle FO, et al. N Engl J Med. 2009;361(5):496‑509.

2. Hotard RS, et al. J Am Acad Dermatol. 2000;42(4):620‑623.

3. Gottlieb AB, et al. Int J Womens Dermatol. 2019;5(3):141‑150.

4. Stein Gold L, et al. J Am Acad Dermatol. 2018;79(2):287‑293.

5. Sugarman JL, et al. J Drugs Dermatol. 2018;17(8):855‑861.

AUTHOR DISCLOSURES
Dr. Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO, Dermavant, Incyte, Novartis, AbbVie, and Lilly. Dr. Boni Elewski has provided 

clinical research support (research funding to University) for Abbvie, Anaptys‑ Bio, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Incyte, Leo, Lilly, Merck, Menlo, Novartis, 

Pfizer, Regeneron, Sun, Ortho Dermatologics, Vanda and as a consultant (received honorarium) from Boehringer Ingelheim, Celgene, Leo, Lilly, Menlo, Novartis, Pfizer, Sun, Ortho 

Dermatologics, Verrica. Dr. Zoe Draelos received funding from Ortho Dermatologics to conduct the research presented in this poster. Dr. Tina Lin is an employee of Ortho 

Dermatologics and may hold stock and/or stock options in its parent company.

FIGURE 1. Overall Treatment Successa by Study Visit in Female and Male Participants (ITT Population, Pooled)

A. Female Participants

HP/TAZ Lotion (n=101)
Vehicle (n=45)

Treatment Posttreatment

P
e
rc

e
n
ta

g
e
 o

f
F
e
m

a
le

 P
a
rt

ic
ip

a
n
ts

12.0%

27.8%

37.9%

44.5%

32.8%

0.1%
4.6%

7.0%
9.9%

3.4%

0%

10%

20%

30%

40%

50%

60%

70%

0 2 4 6 8 12

Study Visit (Weeks)

B. Male Participants

HP/TAZ Lotion (n=175)
Vehicle (n=97)

12

Treatment Posttreatment

P
e
rc

e
n
ta

g
e
 o

f
M

a
le

 P
a
rt

ic
ip

a
n
ts

8.0%

24.9%

37.5% 38.4%
33.6%

2.1%
5.5%

7.7%
9.8% 11.1%

0%

10%

20%

30%

40%

50%

60%

70%

0 2 4 6 8

Study Visit (Weeks)

*P<0.05 vs vehicle, **P<0.01 vs vehicle, ***P<0.001 vs vehicle.
aTreatment success is defined as a ≥2‑grade improvement from baseline in IGA score and a score of ‘clear’ or ‘almost clear’ (0 or 1)
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent‑to‑treat.

FIGURE 2. Treatment Successa in Psoriasis Signs at Week 8 in Female and Male Participants (ITT Population, Pooled)

A. Female Participants

65.5%

24.7%

52.9%

63.8%

17.0%
18.9%

Erythema Plaque Elevation Scaling

P
e
rc

e
n
ta

g
e
 o

f
F
e
m

a
le

 P
a
rt

ic
ip

a
n
ts

HP/TAZ Lotion (n=101)
Vehicle (n=45)

0%

10%

20%

30%

40%

50%

60%

70%

80%

B. Male Participants

43.5%

57.2% 58.8%

13.4 %

20.0% 19.1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Erythema Plaque Elevation Scaling

P
e
rc

e
n
ta

g
e
 o

f
M

a
le

 P
a
rt

ic
ip

a
n
ts

HP/TAZ Lotion (n=175)
Vehicle (n=97)

***P<0.001 vs vehicle.
a Treatment success is defined as a ≥2‑grade improvement from baseline in each individual sign of psoriasis at the target lesion.
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; ITT, intent‑to‑treat.

FIGURE 3. Mean Percent Reduction in Overall Affected Body Surface Area (BSA) by Study Visit in Female and Male Participants (ITT Population, Pooled)

A. Female Participants

HP/TAZ Lotion (n=101)
Vehicle (n=45)

Treatment Posttreatment

P
e
rc

e
n
t 

C
h
a
n
g

e
fr

o
m

 B
a
se

lin
e

-7.3%

-18.0%

-29.7%
-34.2%

-36.8%

-3.1% -3.9%

-9.3% -8.7%

-2.6%

-50%

-40%

-30%

-20%

-10%

0%

10%

20%

0 2 4 6 8 12

Study Visit (Weeks)

B. Male Participants

HP/TAZ Lotion (n=175)
Vehicle (n=97)

Treatment Posttreatment

P
e
rc

e
n
t 

C
h
a
n
g

e
fr

o
m

 B
a
se

lin
e

-8.4%

-22.4%

-32.6%

-39.6%

-32.6%

2.3% 1.2% -0.4% - 0.7%

 5.5%

-50%

-40%

-30%

-20%

-10%

0%

10%

20%

0 2 4 6 8 12

Study Visit (Weeks)

**P<0.01 vs vehicle, ***P≤0.001 vs vehicle.
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; ITT, intent‑to‑treat.