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 2021 • January 16-24, 2021 • Virtual

SYNOPSIS
 � Combining tazarotene (TAZ) with a potent-to-superpotent topical corticosteroid, such as 
halobetasol propionate (HP), is recommended for the treatment of patients with mild-to-
moderate psoriasis1 

 � The TAZ + HP combination may provide synergistic efficacy, increase the duration of 
remission, and reduce side effects of both HP and TAZ when used alone1-3 

 � A once-daily, fixed-combination HP 0.01%/TAZ 0.045% lotion (Duobrii,® Ortho 
Dermatologics) was developed utilizing polymeric emulsion technology, which allows for 
rapid and uniform distribution of HP and TAZ, humectants, and moisturizers on the skin

 � HP/TAZ lotion has demonstrated efficacy and safety in patients with moderate-to-severe 
psoriasis,4,5 including those with lower body surface area (BSA) involvement6

OBJECTIVE
 � To evaluate efficacy and safety of HP 0.01%/TAZ 0.045% lotion in patients with either mild 
scaling or mild plaque elevation at baseline

METHODS
 � In two phase 3, double-blind studies (NCT02462070, NCT02462122), adult participants 
were randomized 2:1 to HP/TAZ or vehicle lotion once daily for 8 weeks, with a 4-week 
posttreatment follow-up4,5

• Participants were required to have an Investigator’s Global Assessment (IGA) score of 
3 (moderate) or 4 (severe) and affected BSA of 3 to 12% at baseline

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

 � Efficacy measures included treatment success (percentage of participants with ≥2-grade 
reduction in IGA score and a score of 0 [clear] or 1 [almost clear]), change in affected BSA, 
and percentage of participants with ≥2-grade improvements from baseline (success) in 
erythema, plaque elevation, and scaling

 � Treatment-emergent adverse events (TEAEs) were evaluated

 � Pooled, post hoc analyses were performed in subsets of patients with either mild scaling 
(score of 2) or mild plaque elevation (score of 2) at baseline

RESULTS

Demographics and Baseline Characteristics
 � Of 418 study participants included in the overall population, 58 had mild scaling at 
baseline and 44 had mild plaque elevation at baseline 

 � Participant demographics and characteristics were generally similar across the groups, though 
there was a higher proportion of males in the mild scaling group and more participants in the 
mild scaling and plaque elevation groups had moderate IGA at baseline (Table 1)

Efficacy 
 � Compared with vehicle, HP/TAZ-treated participants in the mild scaling group had 
significantly greater reductions from baseline in affected BSA (Figure 1), higher rates of 
treatment success (Figure 2), and improvements in signs of psoriasis (Figure 3) at week 8

 � Similar results were observed in the overall population (HP/TAZ vs vehicle at week 8:  
BSA reduction: -37.6% vs -3.1%; treatment success: 40.6% vs 9.9%; erythema success: 
47.0% vs 14.5%; plaque elevation success: 59.6% vs 19.7%; scaling success: 61.2% vs 20.9% 
[P<0.001 for all])5

FIGURE 2.  Treatment Successa in Mild Plaque Elevation and Mild Scaling 
Subgroups (ITT Population, Pooled)

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

0%

70%

0 2 4 6 8 12
Study Visit (Weeks)

Treatment Posttreatment

10%

20%

30%

40%

**

**
**

HP/TAZ Lotion: Mild Plaque Elevation Subgroup (n=30)
HP/TAZ Lotion: Mild Scaling Subgroup (n=36)
Vehicle Lotion: Mild Plaque Elevation Subgroup (n=14)
Vehicle Lotion: Mild Scaling Subgroup (n=22)

50%

60%

*

*

*P<0.05; **P≤0.01 vs vehicle.  
aDefined as ≥2-grade improvement from baseline IGA and a score of “clear” or “almost clear.” 
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator’s Global Assessment; ITT, intent to treat.

FIGURE 3.  Erythema, Plaque Elevation, and Scaling Successa in Mild Plaque 
Elevation and Mild Scaling Subgroups at Week 8 (ITT Population, 
Pooled)

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

0%

100%

Erythema Success

*
61.5%

20%

40%

60%

80%

38.8%

**
50.8%

10.4%

Plaque Elevation Success

*
43.1%

8.2%

**
66.6%

19.4%

Scaling Success

*
72.5%

39.2% **
32.0%

10.2%

HP/TAZ Lotion: Mild Plaque Elevation Subgroup (n=30) HP/TAZ Lotion: Mild Scaling Subgroup (n=36)

Vehicle Lotion: Mild Plaque Elevation Subgroup (n=14) Vehicle Lotion: Mild Scaling Subgroup (n=22)

*P<0.05; **P<0.01 vs vehicle.  
aFor each sign of psoriasis, success defined as ≥2-grade improvement from baseline.  
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; ITT, intent to treat.

CLINICAL COMMENTARY
 � Unlike real-world use, participants in this study were required to continue 
administration of HP/TAZ for 8 continuous weeks—even if they had 
clearance of active psoriasis—which may have contributed to increased 
levels of irritation in the mild subgroups versus the overall population

 � Treatment-emergent irritation may potentially be addressed in the  
clinic by:
• Recommending that patients temporarily interrupt drug use (eg, drug 

holiday) and resume application of the lotion once irritation signs/
symptoms have subsided

• Encouraging the use of moisturizers before resuming treatment

Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for the Treatment of Plaque Psoriasis in Patients with 
Mild Scaling and Mild Plaque Elevation

 � In the mild plaque elevation group, those treated with HP/TAZ demonstrated significantly 
greater improvements in signs of psoriasis at week 8 versus vehicle (Figure 3)

• A numerically higher treatment success rate was observed with HP/TAZ versus vehicle at 
week 8 in the mild plaque elevation group, with significance reached 4 weeks 
posttreatment (Figure 2)

• Lack of statistical separation of HP/TAZ from vehicle for treatment success and BSA 
reduction may be partly attributed to the small population and/or favorable response to 
the vehicle formulation

FIGURE 1.  BSA Reduction in Mild Plaque Elevation and Mild Scaling 
Subgroups (ITT Population, Pooled)

M
e
a
n
 C

h
a
n
g

e
 f

ro
m

 B
a
se

lin
e

-60%

40%

0 2 4 6 8 12
Study Visit (Weeks)

Treatment Posttreatment

-40%

-20%

0%

20%

**

***
**

*

HP/TAZ Lotion: Mild Plaque Elevation Subgroup (n=30)
HP/TAZ Lotion: Mild Scaling Subgroup (n=36)
Vehicle Lotion: Mild Plaque Elevation Subgroup (n=14)
Vehicle Lotion: Mild Scaling Subgroup (n=22)

*P<0.05; **P<0.01; ***P<0.001 vs vehicle. 
No imputation of missing data. N values shown for baseline only. 
BSA, body surface area; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; ITT, intent to treat.

TABLE 1.   Participant Demographics and Baseline Characteristics

Mild  
Scaling  
(n=58)

Mild Plaque 
Elevation  

(n=44)

Overall 
Population 

(N=418)
Age, mean, y 52.1 49.8 50.3
Males, n (%) 40 (69.0) 25 (56.8) 272 (65.1)
White race, n (%) 49 (84.5) 38 (86.4) 358 (85.6)
IGA of 3 (moderate)a 55 (94.8) 43 (97.7) 356 (85.2)
BSA, mean, % 5.5 4.8 5.9
Erythema
   2 – mild 0 0 36 (8.6)
   3 – moderate 51 (87.9) 44 (100) 331 (79.2)
   4 – severe 7 (12.1) 0 51 (12.2)
Plaque elevation
   2 – mild 0 44 (100) 44 (10.5)
   3 – moderate 57 (98.3) 0 320 (76.6)
   4 – severe 1 (1.7) 0 54 (12.9)
Scaling
   2 – mild 58 (100) 0 58 (13.9)
   3 – moderate 0 43 (97.7) 303 (72.5)
   4 – severe 0 1 (2.3) 57 (13.6)

aAll other participants had an IGA score of 4 (severe) at baseline. 
BSA, body surface area; IGA, Investigator’s Global Assessment.

Safety 
 � Treatment-emergent adverse events occurred at generally similar rates in each subgroup 
and the overall population, and most were mild to moderate in severity (Table 2)

 � Rates of contact dermatitis were higher in the HP/TAZ-treated mild scaling and plaque 
elevation subgroups versus the overall population (Table 2)

 � Skin atrophy was reported as an adverse event in only 1 participant who received HP/TAZ 
lotion in the mild scaling group 

TABLE 2.  Treatment-Emergent Adverse Events Through Week 8

Mild Scaling 
Mild Plaque 

Elevation 
Overall 

Population
HP/TAZ 
Lotion 
(n=35)

Vehicle 
Lotion 
(n=22)

HP/TAZ 
Lotion 
(n=29)

Vehicle 
Lotion 
(n=14)

HP/TAZ 
Lotion 
(n=270)

Vehicle 
Lotion 
(n=140)

Any TEAE, n (%) 14 (40.0) 7 (31.8) 12 (41.4) 3 (21.4) 97 (35.9) 30 (21.4)
Treatment-related TEAEs, n (%) 9 (25.7) 3 (13.6) 10 (34.5) 2 (14.3) 55 (20.4) 11 (7.9)
Intensity of treatment-related TEAEs, n (%)
   Mild 3 (8.6) 0 3 (10.3) 2 (14.3) 20 (7.4) 3 (2.1)
   Moderate 5 (14.3) 2 (9.1) 5 (17.2) 0 26 (9.6) 6 (4.3)
   Severe 1 (2.9) 1 (4.5) 2 (6.9) 0 9 (3.3) 2 (1.4)
Most common TEAEsa, n (%)
   Contact dermatitis 4 (11.4) 0 5 (17.2) 0 20 (7.4) 0
   Pruritus 2 (5.7) 1 (4.5) 1 (3.4) 1 (7.1) 8 (3.0) 4 (2.9)
   Pain of skin 0 0 0 1 (7.1) 0 1 (0.7)
   Excoriation 3 (8.6) 0 0 0 5 (1.9) 0
   Folliculitis 0 0 4 (13.8) 0 5 (1.9) 0
   Burning sensationb 0 0 2 (6.9) 1 (7.1) 4 (1.5) 3 (2.1)

aAt least 5% incidence in any treatment group; does not include 3 AEs in which each event was deemed unrelated to treatment (sinusitis, 
nasopharyngitis, and nausea). 
bSystem Organ Class: nervous system disorder. 
AE, adverse event; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; TEAE, treatment-emergent adverse event. 

CONCLUSIONS
 � In two pooled phase 3 studies, HP 0.01%/TAZ 0.045% lotion was 
efficacious and well tolerated following 8 weeks of treatment among 
participants with mild plaque elevation and mild scaling

 � Results were generally similar to the overall study population, indicating 
that HP/TAZ lotion is a viable treatment option for patients with plaque 
psoriasis who have mild signs of scaling and plaque elevation, regardless 
of their IGA severity at baseline

REFERENCES
1. Elmets CA, et al. J Am Acad Dermatol. Online ahead of print, 2020 Jul 30. doi:10.1016/j.

jaad.2020.07.087.
2. Tanghetti E, et al. J Dermatolog Treat. 2019:1-8.
3. Kircik LH, et al. J Drugs Dermatol. 2019;18(3):279-284.

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.

6. Leonardi C, et al. Poster Virtually Presented at Fall Clinical 2020.  

AUTHOR DISCLOSURES
LSG has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis and Lilly; ET has served as 
speaker for Novartis, Ortho Dermatologics, Sun Pharma, Lilly, Galderma, AbbVie, and Dermira; served as a consultant/clinical studies for Hologic, Ortho Dermatologics, and Galderma; and is a 
stockholder for Accure; CL is a consultant for AbbVie, Amgen, Boehringer Ingelheim, Dermira, Eli Lilly, Janssen, LEO Pharma, Pfizer, Sandoz, UCB, and Vitae; an investigator for Actavis, AbbVie, 
Allergan, Amgen, Boehringer Ingelheim, Celgene, Coherus, Cellceutix, Corrona, Dermira, Eli Lilly, Galderma, Glenmark, Janssen, LEO Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Sienna, 
Stiefel, UCB, and Wyeth; and a speaker for AbbVie, Celgene, Novartis, Sun Pharma, and Eli Lilly; SK is an advisory board member/consultant for Abbvie, Galderma, Incyte Corporation, Pfizer Inc., 
Regeneron Pharmaceuticals, and Kiniksa Pharmaceuticals and has received grant funding from Galderma, Pfizer Inc. and Kiniksa Pharmaceuticals; AJ is an employee of Ortho Dermatologics and 
may hold stock and/or stock options in its parent company. 

Linda Stein Gold, MD1; Emil A Tanghetti, MD2; Craig Leonardi, MD3; Shawn G Kwatra, MD4; Abby Jacobson, MS, PA-C5
1Henry Ford Hospital, Detroit, MI; 2Center for Dermatology and Laser Surgery, Sacramento, CA; 3Department of Dermatology, St. Louis University Medical School, St. Louis, MO; 4Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD; 5Ortho Dermatologics*, Bridgewater, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC.