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 2022 • January 14-19, 2022 • Kauai, HI

SYNOPSIS 

 � The pathogenesis of acne is multifactorial, involving 
follicular proliferation of Cutibacterium acnes, 
increased sebum production and inflammation, and 
abnormal keratinization1,2

• Effective treatment requires pharmacologic 
targeting of one or more of these pathophysiologic 
mechanisms2

 � There are numerous prescription oral and topical 
treatments for acne such as benzoyl peroxide (BPO), 
retinoids, antibiotics, and hormonal therapies2

 � Combining three acne treatments (an antibiotic, 
antibacterial, and retinoid) in a once-daily topical 
polymeric dispersion formulation may provide greater 
efficacy and tolerability than single or dyad treatments

 � This is the first study of clindamycin phosphate 1.2%/
BPO 3.1%/adapalene 0.15% (IDP-126) gel, which  
once approved will be the first triple-combination, 
fixed-dose topical acne treatment

OBJECTIVE

 � To evaluate the efficacy, safety, and tolerability of 
IDP-126 in participants with moderate-to-severe acne

METHODS

 � In a phase 2, double-blind, multicenter 12-week study 
(NCT03170388),3 participants aged ≥9 years with 
moderate-to-severe acne were randomized (1:1:1:1:1) to 
once-daily IDP-126 gel, vehicle gel, or 1 of 3 
component dyad combination gels 

 � The Evaluator’s Global Severity Score (EGSS) was 
scored as follows: 0 (clear) = Normal, clear skin/no 
evidence of acne; 1 (almost clear) = Rare 
noninflammatory lesions, with rare noninflamed 
papules; 2 (mild) = Some noninflammatory lesions, 
with few inflammatory lesions; 3 (moderate) = 
Noninflammatory lesions predominate, with multiple 
inflammatory lesions: several/many comedones and 
papules/pustules, ≤1 nodulocystic lesion; 4 (severe) = 
Inflammatory lesions more apparent, many 
comedones/papules/pustules, ≤2 nodulocystic lesions 

FIGURE 1.  Treatment Success a at Week 12  
(ITT Population)

0%

20%

40%

60%

Week 12

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

80%

52.5%

30.3%30.5%

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

27.8%

8.1%

*** *** ***

***

BPO / ADAP Gel (n=150)
CLIN / ADAP Gel (n=150)

***P<0.001 vs IDP-126. 
aDefined as at least a 2-grade reduction from baseline in Evaluator’s Global Severity Score and 
a score of 0 (clear) or 1 (almost clear). 
ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%; 
IDP-126, clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15%; ITT, intent to treat.

FIGURE 2.  Lesion Reduc tions at Week 12  
(ITT Population)

A. In�ammatory Lesions

-100%

-80%

-60%

-40%

LS
 M

e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 F

ro
m

 B
a
se

lin
e 0%

-76.4%

-69.2%
-64.0%

-68.1%

-50.4%

**
**

**

***

-20%

B. Nonin�ammatory Lesions

-100%

-80%

-60%

-40%

LS
 M

e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 F

ro
m

 B
a
se

lin
e 0%

-71.0%

-60.7%-58.7%-61.1%

-45.8%

** *** **

***

-20%

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

BPO / ADAP Gel (n=150)
CLIN / ADAP Gel (n=150)

**P<0.01; ***P<0.001 vs IDP-126. 
Absolute inflammatory and noninflammatory lesion reductions were as follows: IDP-126, 29.9 
and 35.5, respectively; vehicle and dyads, range: 19.6–26.8 and 21.8–30.0 (P<0.05 vs IDP-126, all). 
ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%; 
IDP-126, clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15%; ITT, intent to 
treat; LS, least-squares.

Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe 
Acne: Phase 2 Study of the First Triple-Combination Drug 

 James Q Del Rosso, DO1-3; Leon H Kircik, MD4-6; Linda Stein Gold, MD7; Hilary Baldwin, MD8,9; Jonathan S Weiss, MD10,11; David M Pariser, MD12,13; Valerie Callender, MD14,15; Edward Lain, MD, MBA16; Michael Gold, MD17; Kenneth Beer, MD18; Zoe D Draelos, MD19; 
Neil Sadick, MD20,21; Radhakrishnan Pillai, PhD22; Varsha Bhatt, PhD22; Emil A Tanghetti, MD23
1JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 2Advanced Dermatology and Cutaneous Surgery, Maitland, FL; 3Touro University Nevada, Henderson, NV; 4Indiana University School of Medicine, Indianapolis, IN; 5Physicians Skin Care, PLLC, Louisville, KY; 6Icahn School of Medicine at Mount Sinai, New York, NY; 7Henry Ford Hospital, Detroit, MI; 8The Acne Treatment and Research Center, 
Brooklyn, NY; 9Robert Wood Johnson University Hospital, New Brunswick, NJ; 10Georgia Dermatology Partners, Snellville, GA; 11Gwinnett Clinical Research Center, Inc., Snellville, GA; 12Eastern Virginia Medical School, Norfolk, VA; 13Virginia Clinical Research, Inc., Norfolk, VA; 14Callender Dermatology and Cosmetic Center, Glenn Dale, MD; 15Howard University College of Medicine, Washington DC; 16Austin 
Institute for Clinical Research, Austin, TX; 17Tennessee Clinical Research Center, Nashville, TN; 18University of Miami Miller School of Medicine, Miami, FL; 19Dermatology Consulting Services, PLLC, High Point, NC; 20Weill Cornell Medical College, New York, NY; 21Sadick Dermatology, New York, NY; 22Bausch Health US, LLC, Petaluma, CA*; 23Center for Dermatology and Laser Surgery, Sacramento, CA
*Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc.

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

 � Endpoints were treatment success at week 12 
(≥2-grade reduction from baseline in EGSS and  
clear/almost clear skin) and least-squares (LS) mean 
changes from baseline to week 12 in inflammatory/
noninflammatory lesions

 � Treatment-emergent adverse events (TEAEs) and 
cutaneous safety and tolerability (via 4-point scale 
where 0=none and 3=severe) were also assessed

RESULTS

Participants
 � A total of 741 participants were enrolled (intent-to-
treat population: n=740; safety population: n=725)

 � Mean age was approximately 19.5 years, most 
participants were female and White, and most had 
moderate disease (EGSS 3) at baseline (Table 1)

 � Treatment compliance across treatment groups  
was ≥93%

Efficacy 
 � At week 12, over half of participants achieved 
treatment success with IDP-126 vs ~30% or less with 
vehicle and dyads (P≤0.001, all; Figure 1)

 � IDP-126 also demonstrated significantly greater 
absolute reductions in the number of inflammatory 
and noninflammatory lesions vs vehicle or dyads, 
(P<0.05, all) corresponding to >70% reductions  
(Figure 2)

 � Images depicting acne improvements in IDP-126-
treated participants are shown in Figure 3

Safety
 � TEAE rates were higher with IDP-126 and  
BPO/adapalene vs clindamycin/BPO,  
clindamycin/adapalene, or vehicle at week 12  
(Table 2)

 � Most TEAEs were of mild-to-moderate severity  
(data not shown)

 � With IDP-126, there was no severe scaling, erythema, 
hypopigmentation, or itching, and <5% of participants 
had severe hyperpigmentation, burning, or stinging 
(Table 3)

FIGURE 3.  Acne Improvements with IDP-126

13-Year-Old Female - Black
Baseline: EGSS 3
IL: 46
NIL: 54

Week 12: EGSS 1
IL: 0 (100% reduction)
NIL: 21 (61% reduction)

14-Year-Old Male - Asian
Baseline: EGSS 3
IL: 35
NIL: 40

Week 12: EGSS 0
IL: 0 (100% reduction)
NIL: 0 (100% reduction)

26-Year-Old Female - White
Baseline: EGSS 3
IL: 36
NIL: 41

Week 12: EGSS 1
IL: 1 (97% reduction)
NIL: 3 (93% reduction)

27-Year-Old Female - Black/White
Baseline: EGSS 3
IL: 30
NIL: 42

Week 12: EGSS 1
IL: 4 (87% reduction)
NIL: 5 (88% reduction)

Individual results may vary. All participants self-reported ethnicity as Non-Hispanic/Latino. 
EGSS, Evaluator’s Global Severity Score; IDP-126, clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15%;  
IL, inflammatory lesions; NIL, noninflammatory lesions.

TABLE 1.  Baseline Demographics and Characteristics (ITT Population)

IDP-126  
Gel  

(n=146)

BPO / ADAP 
Gel  

(n=150)

CLIN / BPO 
Gel  

(n=146)

CLIN / ADAP  
Gel  

(n=150)

Vehicle  
Gel  

(n=148)
Age, mean (SD), y 19.9 (7.0) 19.2 (8.0) 19.6 (6.9) 19.4 (6.5) 19.6 (7.1)
Female, n (%) 94 (64.4) 86 (57.3) 91 (62.3) 93 (62.0) 89 (60.1)
Race,a n (%)
   White 98 (67.1) 109 (72.7) 101 (69.2) 109 (72.7) 95 (64.2)

   Black 24 (16.4) 26 (17.3) 30 (20.5) 20 (13.3) 26 (17.6)

   Asian 10 (6.8) 6 (4.0) 8 (5.5) 9 (6.0) 17 (11.5)

Inflammatory lesion 
count, mean (SD)

39.0 (11.8) 39.0 (10.2) 40.0 (12.8) 38.2 (7.9) 38.2 (9.2)

Noninflammatory lesion 
count, mean (SD)

51.8 (20.3) 48.0 (14.7) 49.2 (17.6) 51.1 (18.4) 50.7 (18.7)

EGSS, n (%)
   3 – Moderate 124 (84.9) 119 (79.3) 124 (84.9) 129 (86.0) 127 (85.8)

   4 – Severe 22 (15.1) 31 (20.7) 22 (15.1) 21 (14.0) 21 (14.2)
aAdditional races not shown: American Indian/Alaska Native, Native Hawaiian/Other Pacific Islander, and Other/Multiple. 
ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%; EGSS, Evaluator’s Global Severity Score; 
IDP-126, clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15%; ITT, intent to treat; SD, standard deviation. 

TABLE 2.  Summary of Adverse Events (Safety Population)

Participants, n (%)

IDP-126  
Gel  

(n=141)

BPO / ADAP 
Gel  

(n=146)

CLIN / BPO 
Gel  

(n=144)

CLIN / ADAP  
Gel  

(n=148)

Vehicle  
Gel  

(n=146)
Reporting any TEAE 51 (36.2) 52 (35.6) 26 (18.1) 40 (27.0) 22 (15.1)
Reporting any SAEa 1 (0.7) 0 0 3 (2.0) 0
Discontinued due to 
TEAEb

4 (2.8) 8 (5.5) 0 3 (2.0) 2 (1.4)

Related TEAEs 28 (19.9) 32 (21.9) 3 (2.1) 18 (12.2) 2 (1.4)
Related TEAEs (in ≥5% of participants in any treatment group)
   AS pain 11 (7.8) 16 (11.0) 1 (0.7) 5 (3.4) 1 (0.7)

   AS dryness 9 (6.4) 8 (5.5) 2 (1.4) 9 (6.1) 0

TEAEs leading to discontinuationc (in ≥2% of participants in any treatment group)
   AS pain 2 (1.4) 5 (3.4) 0 2 (1.4) 0
aNone of the SAEs were considered related to study drug. 
b1 participant in the vehicle gel group discontinued the study drug, but not the study, due to a TEAE. 
cPermanent withdrawal of study drug and/or early study discontinuation. 
ADAP, adapalene 0.15%; AE, adverse event; AS, application site; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%; IDP-126, 
clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15%; SAE, serious adverse event; TEAE, treatment-emergent adverse event.

TABLE 3.  Severe (Grade 3) Cutaneous Safety and Tolerability Assessmentsa 
(Safety Population)

Participants, n (%)
IDP-126 Gel 

(n=141)
BPO / ADAP 
Gel (n=146)

CLIN / BPO 
Gel (n=144)

CLIN / ADAP 
Gel (n=148)

Vehicle Gel 
(n=146)

Scaling 0 2 (1.4) 0 2 (1.4) 0
Erythema 0 2 (1.4) 0 3 (2.0) 0
Hyperpigmentation 2 (1.4) 3 (2.1) 2 (1.4) 3 (2.0) 1 (0.7)
Itching 0 1 (0.7) 0 0 1 (0.7)
Burning 6 (4.3) 8 (5.5) 0 1 (0.7) 0
Stinging 3 (2.1) 6 (4.1) 0 0 0
aInvestigator-assessed evaluations were scaling, erythema, hypopigmentation, and hyperpigmentation; participant-assessed evaluations 
were itching, burning, and stinging. Hypopigmentation is not shown as there were no severe cases. 
ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%; IDP-126, clindamycin phosphate 1.2%/benzoyl 
peroxide 3.1%/adapalene 0.15%.

CONCLUSIONS
 � Once-daily treatment with the novel fixed-dose triple-combination 
clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel  
(IDP-126) in a polymeric dispersion system showed superior efficacy 
to vehicle gel and three dyad component gels over 12 weeks in this 
phase 2 study of adult, adolescent, and pediatric participants with 
moderate-to-severe acne

 � IDP-126 was also safe and well tolerated with low rates of 
discontinuations

 � Overall, the efficacy and safety profiles of IDP-126 demonstrate its 
potential as a new treatment option in the acne armamentarium 

REFERENCES
1. Del Rosso JQ, Schmidt NF. Cutis. 2010;85(1):15–24.

2. Zaenglein AL, et al. J Am Acad Dermatol. 2016;74(5):945–73.

3. Stein Gold, L, et al. Am J Clin Dermatol. 2021. doi: 10.1007/s40257-021-00650-3. 

AUTHOR DISCLOSURES
JQDR 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 LHK has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. LSG has served as investigator/consultant or speaker for Ortho 
Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis and Lilly. HB has served as advisor, investigator, and on speakers’ bureaus for Almirall, 
Cassiopea, Foamix, Galderma, Ortho Dermatologics, Sol Gel, and Sun Pharma. JSW is a consultant, speaker, advisor, and/or researcher for AbbVie, Ortho Dermatologics, Janssen Biotech, 
Dermira, Almirall, Brickell Biotech, DermTech, Scynexis. DMP has served as consultant to Atacama Therapeutics, Bickel Biotechnology, Biofrontera AG, Celgene, Dermira, LEO Pharma, Regeneron, 
Sanofi, TDM SurgiTech, TheraVida, and Ortho Dermatologics; investigator for Abbott Laboratories, Almirall, Amgen, AOBiome, Asana Biosciences, Bickel Biotechnology, Celgene, Dermavant, 
Dermira, Eli Lilly, LEO Pharma, Menlo Therapeutics, Merck & Co., Novartis, Novo Nordisk A/S, Ortho Dermatologics, Pfizer, Regeneron, and Stiefel; on advisory board for Pfizer; and on the data 
monitoring board for BMS. VC has served as an investigator, consultant, or speaker for AbbVie, Galderma, L’Oréal, Ortho Dermatologics, and Vyne. EL has nothing to disclose. MG has acted as 
an investigator, advisor, speaker, and consultant for Ortho Dermatologics. KB has received funding from Allergan, Galderma, Evolus, and Revance.  ZDD received research funding from Ortho 
Dermatologics. NS has served on advisory boards, as a consultant, investigator, speaker, and/or other and has received honoraria and/or grants/research funding from Almirall, Actavis, Allergan, 
Anacor Pharmaceuticals, Auxilium Pharmaceuticals, Bausch Health, Bayer, Biorasi, BTG, Carma Laboratories, Cassiopea, Celgene Corporation, Cutera, Cynosure, DUSA Pharmaceuticals, 
Eclipse Medical, Eli Lilly and Company, Endo International, EndyMed Medical, Ferndale Laboratories, Galderma, Gerson Lehrman Group, Hydropeptide, Merz Aesthetics, Neostrata, Novartis, 
Nutraceutical Wellness, Palomar Medical Technologies, Prescriber’s Choice, Regeneron, Roche Laboratories, Samumed, Solta Medical, Storz Medical AG, Suneva Medical, Vanda Pharmaceuticals, 
and Venus Concept. VB and RP are employees of Bausch Health US, LLC and may hold stock and/or stock options in its parent company. EAT 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..