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 Miami 2023 • February 17-20, 2023 • Miami, FL

SYNOPSIS 
 � Adherence to acne treatment is highest 
when the outcome is rapid and substantial1

 � However, many acne medication regimens 
may take weeks or months to produce an 
improvement discernible by patients, leading 
to lower adherence2 

 � A three-pronged combination approach 
using once-daily application of an antibiotic, 
antibacterial, and retinoid may provide faster 
improvement than stand alone or dual 
combination products 

 � The first triple-combination, fixed-dose acne 
topical in development, clindamycin 
phosphate 1.2%/benzoyl peroxide (BPO) 
3.1%/adapalene 0.15% (IDP-126) gel, was 
efficacious and safe in 3 clinical studies3,4

OBJECTIVE
 � To determine threshold lesion reductions for 
IDP-126 gel and compare to its dyads and 
vehicle gel  

METHODS
 � A phase 2 (N=741; NCT03170388) and two 
phase 3 (N=183; N=180; NCT04214639; 
NCT04214652), double-blind, 12-week 
studies enrolled participants aged ≥9 years 
with moderate-to-severe acne

 � Participants were randomized to receive 
once-daily IDP-126 or vehicle gel; the phase 
2 study included three additional dyad gel 
randomization arms: BPO/adapalene; 
clindamycin phosphate/BPO; and 
clindamycin phosphate/adapalene

 � Endpoints included least-squares mean 
percent change from baseline in 
inflammatory and noninflammatory  
lesion counts

 � The percentage of participants achieving 
≥33%, ≥50%, and ≥75% thresholds in lesion 
reduction was evaluated

RESULTS
FIGURE 1. ONE-THIRD REDUCTION IN 
LESION COUNTS: WEEK 4

40%

0%

100%

80%

60%

20%

40%

0%

100%

80%

60%

20%

n= 146 150 146 150 148 242 121

82.7%

65.9%
69.8% 68.6%

64.1%

78.9%

56.8%

n= 146 150 146 150 148 242 121

68.9%

62.3%

49.8%

58.5%

41.3%

63.5%

50.1%

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

In�ammatory Lesions

Phase 2 Study Phase 3 Pooled

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

Nonin�ammatory Lesions

Phase 2 Study Phase 3 Pooled

Early reductions in
acne lesions by week 4
More participants achieved 

one-third reduction in lesions 
with IDP-126 versus dyads 

and vehicle at week 4

IDP-126 BPO/ADAP CLIN/BPO CLIN/ADAP VEH

Dyads signi�cantly
lower vs IDP-126

Dyad signi�cantly
lower vs IDP-126

Participants
with

≥33%
reduction at

week 4

*P<0.05, **P<0.01, ***P<0.001 active treatment vs vehicle. 
#P<0.05, ##P<0.01, ###P≤0.001 dyads vs IDP-126.  
ADAP, adapalene; BPO, benzoyl peroxide; CLIN, clindamycin phosphate; VEH, vehicle. 

FIGURE 2. ONE-HALF REDUCTION IN LESION COUNTS: 
WEEKS 4 –12

40%

0%

100%

80%

60%

20%

40%

0%

100%

80%

60%

20%

Phase 2 study Phase 3 pooled

40%

0%

100%

80%

60%

20%

40%

0%

100%

80%

60%

20%

Phase 2 study Phase 3 pooled

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

In�ammatory Lesions

BL

Nonin�ammatory Lesions

BL

Early and sustained reductions in acne lesions
More participants achieved one-half reduction in lesions with IDP-126

versus dyads and vehicle as early as week 4, with signi�cant
reduction maintained at weeks 8 and 12

88.7%

78.2%

77.4%
77.9%

55.9%

37.9%

56.0%

63.9%

86.5%

17.8%

IDP-126 Gel (n=146)
BPO/ADAP Gel (n=150)
CLIN/BPO Gel (n=146)
CLIN/ADAP Gel (n=150)
Vehicle Gel (n=148)

IDP-126 Gel (n=242)
Vehicle Gel (n=121)

79.1%

58.5%

36.0%

P
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rc

e
n
ta

g
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f 
P

a
rt

ic
ip

a
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ts

BL BL

84.6%

68.3%

71.4%
70.5%

51.5%

32.5%

48.4%
54.0%

84.3%

15.5%

IDP-126 Gel (n=146)
BPO/ADAP Gel (n=150)
CLIN/BPO Gel (n=146)
CLIN/ADAP Gel (n=150)
Vehicle Gel (n=148)

IDP-126 Gel (n=242)
Vehicle Gel (n=121)

65.1%

44.4%

20.4%

All dyads signi�cantly lower vs
IDP-126 at weeks 4, 8, and 12

All dyads signi�cantly lower vs
IDP-126 at weeks 8 and 12

Participants
with

≥50%
reduction at

all weeks

Week
2

Week
4

Week
8

Week
12

Week
2

Week
4

Week
8

Week
12

Week
2

Week
4

Week
8

Week
12

Week
2

Week
4

Week
8

Week
12

*P<0.05, **P≤0.01, ***P≤0.001 active treatment vs vehicle. 
#P<0.05, ##P<0.01 dyads vs IDP-126. 
ADAP, adapalene; BPO, benzoyl peroxide; CLIN, clindamycin phosphate; VEH, vehicle.

FIGURE 3. THREE-FOURTHS REDUCTIONS 
IN LESION COUNTS: WEEK 12 

40%

0%

100%

80%

60%

20%

40%

0%

100%

80%

60%

20%

n= 146 150 146 150 148 242 121

65.8%

51.2% 50.1% 49.9%

21.6%

68.1%

33.4%

n= 146 150 146 150 148 242 121

53.2%

38.3% 36.9%
40.2%

18.9%

55.0%

24.8%

P
e
rc

e
n
ta

g
e
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f 
P

a
rt

ic
ip

a
n
ts

In�ammatory Lesions

Phase 2 Study Phase 3 Pooled

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

Nonin�ammatory Lesions

Phase 2 Study Phase 3 Pooled

Substantial reductions in
acne lesions by week 12
Signi�cantly more participants

achieved three-fourths reduction
in lesions with IDP-126 versus
dyads and vehicle at week 12

IDP-126 BPO/ADAP CLIN/BPO CLIN/ADAP VEH

Dyads signi�cantly
lower vs IDP-126

Dyads signi�cantly
lower vs IDP-126

Participants
with

≥75%
reduction at

week 12

***P≤0.001 active treatment vs vehicle. 
#P<0.05, ##P≤0.01 dyads vs IDP-126. 
ADAP, adapalene; BPO, benzoyl peroxide; CLIN, clindamycin phosphate; VEH, vehicle.

Early and Sustained Reductions in Moderate-to-Severe Acne With Fixed-Dose  
Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel 

Julie C Harper, MD1; Leon H Kircik, MD2-4; Michael Gold, MD5; Adelaide A Hebert, MD6; Jeffrey L Sugarman, MD, PhD7; Lawrence Green, MD8; Linda Stein Gold, MD9; Hilary Baldwin, MD10; James Q Del Rosso, DO11-13; Eric Guenin, PharmD, PhD, MPH14
1Dermatology & Skin Care Center of Birmingham, Birmingham, AL; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3Indiana University Medical Center, Indianapolis, IN; 4Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY; 5Tennessee Clinical Research Center, Nashville, TN; 6UTHealth McGovern Medical School, Houston; Houston, TX; 7University of California, San Francisco, CA;  
8George Washington University School of Medicine, Washington, DC; 9Henry Ford Hospital, Detroit, MI; 10The Acne Treatment and Research Center, Brooklyn, NY; 11JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 12Advanced Dermatology and Cosmetic Surgery, Maitland, FL; 13Touro University Nevada, Henderson, NV; 14Ortho Dermatologics, Bridgewater, NJ*
*Ortho Dermatologics is a division of Bausch Health US, LLC 

CONCLUSIONS
 � Therapeutic effects of IDP-126 
gel were rapid and sustained

 � Lesion count reductions were 
greater with IDP-126 versus its 
dyads and vehicle gel as early as 
week 4, with substantial 
reductions observed after 12 
weeks of IDP-126 treatment

 � This fast-acting feature of  
IDP-126—coupled with its 
optimized efficacy, once a  
day application, and good 
tolerability—may positively 
impact treatment adherence

REFERENCES
1. Sevimli Dikicier B. J Int Med Res. 2019;47(7):2987-2992.

2. Tuchayi SM. Patient Prefer Adherence. 2016;10:2091–2096.

3. Stein Gold L. Am J Clin Dermatol. 2022;23(1):93-104.

4. Stein Gold L. J Am Acad Dermatol. 2022;87(3):Supp AB50.

AUTHOR DISCLOSURES
Julie Harper has received honoraria from Aclaris, Almirall, 
BioPharmX, Cassiopea, Cutanea, Dermira, Foamix, Galderma, 
LaRoche-Posay, Ortho Dermatologics, and Sun. Leon Kircik has 
acted as an investigator, advisor, speaker, and consultant for 
Ortho Dermatologics. Michael Gold has acted as an investigator, 
advisor, speaker, and consultant for Ortho Dermatologics. 
Adelaide A. Hebert has received honoraria from Galderma, LEO 
Pharma, Amirall, Cassiopea, Ortho Dermatologics, Cutanea, 
Ferrer, Pfizer, Demira. The UTHealth McGovern Medical School 
had received research grants from Cassiopea, Demira, Ortho 
Dermatologics. Jeffrey L Sugarman is a consultant for Ortho 
Dermatologics, Bausch Health, Regeneron, Sanofi, Verrica, and 
Pfizer. Lawrence Green has served as investigator, consultant, or 
speaker for Almirall, Cassiopea, Galderma, Ortho Dermatologics, 
Sol Gel, Sun Pharma, and Vyne. Linda Stein Gold has served as 
investigator/consultant or speaker for Ortho Dermatologics, 
LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun 
Pharma, UCB, Arcutis, and Lilly. Hilary Baldwin has served as 
advisor, investigator, and on speakers’ bureaus for Almirall, 
Cassiopea, Foamix, Galderma, Ortho Dermatologics, Sol Gel, 
and Sun Pharma. James Q. Del Rosso has served as a consultant, 
investigator, and/or speaker for Ortho Dermatologics, Abbvie, 
Amgen, Arcutis, Dermavant, EPI Heath, Galderma, Incyte, 
LEO Pharma, Lilly, MC2 Therapeutics, Pfizer, Sun Pharma, and 
UCB. Eric Guenin is an employee of Ortho Dermatologics and 
may hold stock and/or stock options in its parent company.