OBJECTIVE
• In this post hoc analysis of a 52-week open-label  

study (NCT02462083),1 we assessed the efficacy  
and safety of once-daily halobetasol propionate  
(0.01%) and tazarotene (0.045%) lotion (HP/TAZ)  
in 550 participants with psoriasis stratified by  
baseline signs and symptoms of disease 

CONCLUSIONS
• Long-term use of HP/TAZ was generally associated 

with treatment success regardless of baseline 
symptom severity, and no new safety signals emerged 
over 52 weeks

• Participants with mild baseline symptoms were less 
likely to experience local skin reactions postbaseline 
compared with participants with more severe baseline 
symptoms

• Evaluation of patients’ baseline itch, dryness, and 
stinging/burning may help predict outcomes of  
HP/TAZ treatment

• Clinicians can use this information to counsel patients 
regarding treatment expectations when initiating  
HP/TAZ

SYNOPSIS
• Topical psoriasis treatments may be used as 

monotherapy for mild disease or as adjunct therapy 
for more severe disease2

• Fixed-combination halobetasol propionate (0.01%) 
and tazarotene (0.045%) lotion (HP/TAZ) is 
approved for treatment of plaque psoriasis in adults3

• Given that patients’ experiences with psoriasis differ 
greatly, further consideration and assessment of the 
utility of HP/TAZ in patients with varying symptom 
severity is warranted 

METHODS
• All participants received once-daily HP/TAZ for  

8 weeks (Figure 1)
• At week 8, participants who achieved the primary 

endpoint of treatment success (defined as 
investigator’s global assessment [IGA] of clear [0] 
or almost clear [1]) stopped HP/TAZ and were 
reevaluated every 4 weeks and retreated as needed 
through 52 weeks. Those who did not achieve 
treatment success at week 8 continued HP/TAZ

• Participants were allowed 24 continuous weeks 
of HP/TAZ treatment if they achieved ≥1-grade 
improvement in IGA from baseline at week 12, with 
monthly reevaluation for achievement of IGA 0/1

• In this post hoc analysis, 550 participants were 
stratified by baseline severity of itch, dryness, and 
stinging/burning (none to mild vs moderate to 
severe)

 – Itch and stinging/burning were scored on a scale from 
0 (none) to 3 (severe) as reported by the participant 
in the past 24 hours

 – Dryness was scored on a scale from 0 (none) to 3 
(severe) as assessed by the investigator

Figure 1. Design of the long-term open-label study 
of HP/TAZ. 

HP/TAZ, halobetasol propionate (0.01%) and tazarotene (0.045%) lotion; IGA, 
investigator’s global assessment. aTreatment success defined as IGA score of clear (0) or 
almost clear (1) and ≥2-grade improvement from baseline IGA. bImprovement defined 
as ≥1-grade improvement from baseline IGA; those demonstrating improvement 
continued the study and were subsequently managed in 4-week cycles  
(ie, treated with once-daily HP/TAZ if they did not achieve treatment success or 
received no treatment until the next evaluation if they achieved treatment success). 
Maximum continuous exposure was 24 weeks.

RESULTS
Participant population
• Baseline characteristics are shown in Table 1

Table 1. Participants Stratified by Baseline Severity of Signs/Symptoms

Efficacy
• At week 52, a greater proportion of participants with none-to-mild baseline 

signs/symptoms had treatment success (IGA 0 or 1) compared with participants 
with moderate-to-severe baseline signs/symptoms (Figure 2)

Figure 2. Treatment success at week 52 among participants treated with  
HP/TAZ stratified by baseline severity of itch, dryness, and stinging/burning.

HP/TAZ, halobetasol propionate (0.01%) and tazarotene (0.045%) lotion; IGA, investigator’s global assessment. aTreatment success 
defined as IGA of clear (0) or almost clear (1). 

• Participants with none-to-mild signs/symptoms at baseline were more likely 
to experience no signs/symptoms at any time point postbaseline relative to 
participants with moderate-to-severe signs/symptoms at baseline (Figure 3)

Figure 3. Participants without signs/symptoms at any time point postbaseline 
stratified by baseline severity of itch, dryness, and stinging/burning.

• Participants with moderate-to-severe itch (Figure 4A), dryness (Figure 4B), or 
burning/stinging (Figure 4C) at baseline were more likely to experience moderate-
to-severe postbaseline local skin reactions

Figure 4. Of the participants who experienced moderate-to-severe 
postbaseline signs/symptoms stratified by baseline severity of (A) itch, (B) 
dryness, and (C) burning/stinging.

Safety
• Rates of adverse events (AEs) were similar across groups and discontinuations 

due to AEs were low (range, 5.6%-8.3% across baseline subgroups), similar to 
what was seen in the overall population1

• Application site dermatitis was the most common treatment-emergent AE across 
groups (Table 2)

Table 2. Treatment-Emergent Adverse Events Stratified by Baseline Severity of 
Signs/Symptoms

 

Long-term Outcomes 
of Fixed-Combination 
Halobetasol Propionate 
and Tazarotene Lotion 
Stratified by Baseline 
Signs and Symptoms  
of Psoriasis

Leon Kircik,1 Lawrence Green,2 Joshua Zeichner,3 Javier Alonso,4 Abby Jacobson5
1Icahn School of Medicine at Mount Sinai, New York, NY; 2George Washington University School of Medicine, Washington, DC; 3Skin and Laser Center at Mount Sinai, New York, NY; 4Coral Gables Dermatology & Aesthetics, 
Coral Gables, FL; 5Ortho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ

Acknowledgments: This study was sponsored by Ortho Dermatologics. Medical writing 
support was provided by MedThink SciCom and funded by Ortho Dermatologics. Ortho 
Dermatologics is a division of Bausch Health US, LLC. 

References: 1. Lebwohl et al. J Eur Acad Dermatol Venereol. 2021;35:1152-1160. 2. Elmets et al.  
J Am Acad Dermatol. 2021;84:432-470. 3. Duobrii [package insert]. Bausch Health US, LLC; 2019. 

 Presented at the Fall Clinical Dermatology Conference • October 21-24, 2021 • Las Vegas, NV, and Virtual Sponsored by Ortho Dermatologics, a division of Bausch Health US, LLC.

Participants, n (%)
Sign/Symptom None to mild Moderate to severe
Itch 278 (50.5) 272 (49.5)
Dryness 289 (52.5) 261 (47.5)
Stinging/Burning 466 (84.7) 84 (15.3)

Participants, n (%)

Application  
site TEAE

None-to-mild 
baseline itch

Moderate-
to-severe 

baseline itch

None-to-mild 
baseline  
dryness

Moderate- 
to-severe  
baseline  
dryness

None-to- 
mild baseline 

stinging/
burning

Moderate- 
to-severe  
baseline  
stinging/
burning

Dermatitis 34 (12.2) 25 (9.2) 38 (13.1) 21 (8.0) 50 (10.7) 9 (10.7)

Pruritis 12 (4.3) 21 (7.7) 16 (5.5) 17 (6.5) 27 (5.8) 6 (7.1)

Pain 9 (3.2) 20 (7.4) 14 (4.8) 15 (5.7) 24 (5.2) 5 (6.0)

Irritation 8 (2.9) 6 (2.2) 10 (3.5) 4 (1.5) 13 (2.8) 1 (1.2)

Erosion 7 (2.5) 5 (1.8) 9 (3.1) 3 (1.1) 10 (2.1) 2 (2.4)

Erythema 4 (1.4) 4 (1.5) 6 (2.1) 2 (0.8) 7 (1.5) 1 (1.2)

Atrophy 0 4 (1.5) 1 (0.3) 3 (1.1) 2 (0.4) 2 (2.4)

TEAE, treatment-emergent adverse event.

34.0 32.0
42.047.0 47.0

21.0

0

20

40

60

80

100

Itch Dryness Stinging/Burning

Pa
rt

ic
ip

an
ts

 a
ch

ie
vi

ng
 

tr
ea

tm
en

t 
su

cc
es

s,
 %

a

Baseline sign/symptom

None to mild
Moderate to severe

Figure 2

17.6 17.6

40.3

4.4 4.2 7.1

0

20

40

60

80

100

Itch Dryness Stinging/Burning

Pa
rt

ic
ip

an
ts

 w
it
ho

ut
 

po
st

ba
se

lin
e 

si
gn

/s
ym

pt
o
m

, %

Baseline sign/symptom

None to mild
Moderate to severe

Figure 3

59.9

37.1

46.8

23.7

0 20 40 60 80 100

Dryness

Stinging/Burning

Participants with moderate-to-severe postbaseline sign/symptom, %

Po
st

ba
se

lin
e 

si
gn

/s
ym

pt
o
m

None-to-mild baseline itch

Moderate-to-severe baseline itch

72.4

31.8

57.4

29.1

0 20 40 60 80 100

Itch

Stinging/Burning

Participants with moderate-to-severe postbaseline sign/symptom, %

Po
st

ba
se

lin
e 

si
gn

/s
ym

pt
o
m

None-to-mild baseline dryness
Moderate-to-severe baseline dryness

83.3

77.4

61.2

48.9

0 20 40 60 80 100

Itch

Dryness

Participants with moderate-to-severe postbaseline sign/symptom, %

Po
st

ba
se

lin
e 

si
gn

/s
ym

pt
o
m

None-to-mild baseline
stinging/burning

Moderate-to-severe
baseline stinging/burning

A

B

C

Figure 1: Study Design

Week 52Day 0 Week 8 Week 12 Week 24
Screening

Once-daily
HP/TAZ for

8 weeks

Evaluated for
treatment success
at week 8a

Success
Treatment 
stopped
for 4 weeks

No success
Continued
once-daily 
HP/TAZ
for 4 weeks

Evaluated for
improvement
at week 12b

Continued study and managed in 4-week cycles for up to 1 year, with 
participants reevaluated every 4 weeks for treatment success

• Success: Treatment stopped for 4 weeks

• No success: Continued once-daily HP/TAZ for 4 weeks

No improvement Discontinued
from study

If 24 weeks of continuous treatment were received 
at any point in the study and the participant did not 
achieve an IGA score of 0 or 1, the participant was 
discontinued from the study.