ACKNOWLEDGEMENTS Study and poster funded by Galderma Laboratories, L.P., Fort Worth, TXGalderma would like to thank Drs. Swinyer, Browning, Hull, T Schlesinger, Mandy, Cook-Bolden, Grekin, Green, Draelos, Werschler, J Schlesinger, and Thiboutot for their participation in this study.

INTRODUCTION
• Acne vulgaris (AV) is the 8th most prevalent disease worldwide

 - AV affects an estimated 85% of individuals between 12 and 24 years of age1,2
• Prompt and effective treatment is needed to prevent long term consequences, such as scarring
• Oral isotretinoin (OI) is considered an effective treatment for many severe AV patients;

however,
 - OI has known and serious side effects
 - Treatment cannot always be initiated immediately

· Isotretinoin is a potent teratogen, and exposure should be avoided by women who are
or may become pregnant

• Current acne treatment guidelines for first-line treatment of severe acne suggest using OI or
a topical therapy combined with oral antibiotics3

 - Adapalene 0.3%/benzoyl peroxide 2.5% (A/BPO 0.3%/2.5%) gel is approved for the
treatment of AV
· A/BPO 0.3%/2.5% gel attacks 3 of the 4 major pathogenic factors of AV
· A/BPO 0.3%/2.5% gel has strong clinical efficacy and excellent safety and tolerability

in subjects with moderate to severe AV4

EFFICACY AND SAFETY OF ADAPALENE 0.3% / BENZOYL PEROXIDE 2.5% GEL PLUS DOXYCYCLINE IN SUBJECTS WITH SEVERE INFLAMMATORY ACNE (NON-NODULOCYSTIC) THAT ARE CANDIDATES FOR ORAL ISOTRETINOIN
James Del Rosso, DO1; Linda Stein Gold, MD2; Sandra Marchese Johnson, MD, FAAD3; Maria Jose Rueda, MD4; Hilary Baldwin, MD5; Edward L. Lain, MD6; Megan Landis, MD7; Marta Rendon, MD8; Emil Tanghetti, MD9, Jonathan Weiss, MD11

1JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 2Henry Ford Medical Center, Dept. of Dermatology, Detroit, MI; 3Johnson Dermatology, Fort Smith, AR; 4Galderma Laboratories, L.P., Fort Worth, TX; 5The Acne Treatment and Research Center, Morristown, NJ; 6Austin Institute for Clinical Research, Pflugerville, TX; 7Dermatology Specialists Research, New Albany, IN; 
8Rendon Center for Dermatology and Aesthetic Medicine, Boca Raton, FL; 9Center for Dermatology and Laser Surgery, Sacramento, CA, 11Gwinnett Dermatology, Snellville, GA

EPI.P-MA10355-07

SUMMARY
■ This study observed that 12 weeks of A/BPO 0.3%/2.5% gel plus DOX 200 mg

was an effective, safe, and well tolerated therapy for subjects with severe AV
(non-nodulocystic, non-conglobate)
 - Mean lesion count reduction and mean percent reduction in lesions were significant

compared with baseline (P < .0001 vs baseline, all study visits)
 - 37.1% of subjects received an IGA of clear or almost clear (IGA success) at week 12
 - Most subjects (80.1%) were no longer assessed as candidates for OI by the

investigators after 12-weeks of A/BPO 0.3%/2.5% gel plus DOX 200 mg treatment
■ Twelve weeks of A/BPO 0.3%/2.5% gel plus DOX 200 mg is an effective and safe

regimen
 - For subjects with severe AV (non-nodulocystic, non-conglobate) who are also

candidates for OI
 - For subjects who must wait before starting oral isotretinoin
 - As an alternative option for those unwilling to use oral isotretinoin
 - For those unable to use oral isotretinoin due to contraindications

SUBJECTS and METHODS
• Open label, single arm, 12-week, multicenter study of A/BPO 0.3%/2.5% gel+DOX† 200 mg
• Twenty-three sites enrolled males and females, 12 years of age or older, with a clinical diagnosis

of severe inflammatory acne (Investigator's Global Assessment [IGA] score = 4) who had
never received OI, and, in the opinion of the investigator, were candidates for OI

 - Subjects had ≤ 4 nodules/cysts > 1 cm in diameter on the face
· Subjects were excluded if they had nodulocystic or conglobate acne, acne fulminans, or

secondary acne (eg, chloracne, drug-induced acne)
• Treatments:

 - Topical A/BPO 0.3%/2.5% gel, once daily for 12 weeks
 - DOX 200 mg (2x 50 mg tablets, Mayne, DORYX), twice daily (morning and evening) for 12

weeks
 - Cetaphil® Gentle Cleanser* (or equivalent), twice daily
 - Cetaphil® Daily Facial Moisturizer SPF 15* (or equivalent), at least once daily and re-apply 

as needed

• Endpoints and Assessments:
 - Reduction and percent reduction in lesions at Weeks 4, 8, and 12
 - IGA (IGA, 0 – 4 scale): Success (subjects rated IGA 0 or 1) at weeks 0, 4, 8, and 12
 - Number and percent of subjects who, in the opinion of the investigator, are candidates for

oral isotretinoin at Weeks 0, 4, 8, and 12
· Investigator evaluation of each subject’s candidacy to OI was performed independently

at each visit, without consideration of previous visits
 - Photographs were taken of all subjects enrolled in the study at all study visits
 - Incidence of adverse events (AEs) and local tolerability (0 [none] – 3 [severe] scale)

*Cetaphil® Gentle Cleanser and Cetaphil® Daily Facial Moisturizer SPF 15 are manufactured by Galderma Laboratories, L.P.
†DOX = doxycycline 200 mg (2x 50 mg tablets, Mayne, DORYX)

*P < .0001

100

0

20

80

40

60

Pe
rce

nt
 o

f S
ub

je
cts

Baseline Week 4 Week 8 Week 12

0.5%
n = 1

3.8%
n = 7

4.8%
n = 9 23.1%

n = 43

33.3%
n = 62

32.3%
n = 60

40.3%
n = 75

38.7%
n = 72

37.1%
n = 69

20.4%
n = 38

12.9%
n = 24

100.0%
n = 186

25.8%
n = 48

15.6%
n = 29

11.3%
n = 21

41.9%
n = 78

65.1%
n = 121

80.1%
n = 149

100.0%
n = 186

58.1%
n = 108

34.9%
n = 65

19.9%
N = 37

OI IGA OI IGA OI IGA OI IGA

IGA 0: Clear IGA 1: Almost Clear IGA 2: Mild IGA 3: Moderate IGA 4: Severe OI Candidate

* * *

Success = 0 (0) Success* = 9 (4.8%) Success* = 44 (23.7%) Success* = 69 (37.1%)

Figure 1. Investigator Assessed OI Candidacy and IGA by Study Visit 
(ITT, LOCF, n = 186)

REFERENCES
1. Tan JK, Bhate K. A global perspective on the epidemiology of acne. Br J Dermatol. Jul 2015;172 Suppl 1:3-12.
2. Landis ET, Davis SA, Taheri A, Feldman SR. Top dermatologic diagnoses by age. Dermatol Online J. 2014;20(4):22368.
3. Gollnick HP, Bettoli V, Lambert J, et al. A consensus-based practical and daily guide for the treatment of acne patients. J Eur Acad Dermatol Venereol. 

Sep 2016;30(9):1480-1490.
4. Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy

by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study.
Am J Clin Dermatol. Jun 2016;17(3):293-303.

Figure 5. Representative Subject Photographs
Subject 147-003: 18 Year Old Male Subject 108-026: 19 Year Old Female Subject 108-028, 14 Year Old Male

I/N - 61/64, IGA - 4, Y I/N - 60/120, IGA - 4, YI/N 41/22, IGA 4, Y I/N 3/8, IGA 1, N I/N 16/26, IGA 3, YI/N 6/33, IGA 1, N

Baseline Baseline BaselineWeek 12 Week 12Week 12

I/N = Inflammatory/ Noninflammatory Lesions Y = Investigator Opinion: This subject is a candidate for oral isotretinoin N = Investigator Opinion: This subject is not a candidate for oral isotretinoin

RESULTS
• The study enrolled 186 subjects

 - 175 subjects received at least one dose of the study treatment
 - Male (n = 78) and female (n = 97)
 - Mean age = 19.6 ± 7.3 (56% ≤ 17 years of age)
 - Most subjects were white (79%) and not Hispanic or Latino (81%)
 - Baseline lesion counts; Mean (SD)

· Inflammatory = 44.8 (21.7); Non-inflammatory = 65.3 (39.4); Total = 110.1 (49.4)
• Subjects who were NOT considered candidates for OI by the investigator (Figure 1)

 - 41.9% after 4 weeks; 65.1% after 8 weeks; 80.1% (149/186) after 12 weeks
• 75.8% of subjects were rated IGA 2 (mild) or better by week 12 (Figure 1)
• IGA success rate (clear and almost clear; Figure 1)

 - 4.8%  at week 4; 23.7% at week 8; 37.1% at week 12
• Mean number of lesions: Significantly reduced compared with baseline (P < .0001 vs

baseline, all study visits; Figure 2)
 - At week 12 the total mean reduction in lesions was -26.2 lesions compared with baseline

(P < .0001)
• Percent lesion reduction: Significant reduction compared with baseline (P < .0001 vs

baseline, all study visits; Figure 3)
 - At week 12 the total mean percent reduction in lesions was -62.6% compared with

baseline (P < .0001)
• Safety

 - A/BPO 0.3% was well tolerated and most AEs were mild (Figure 4)
 - The number of subjects experiencing any treatment emergent AE was 46 (26.3%)
 - The number of subjects with any treatment related AE was 27 (15.4%)
 - The most common treatment related AEs were skin burning sensation (n = 6, [3.4%])

and erythema (n = 5, [2.9%])

120

20

60

100

40

80

0

M
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n 
Le

sio
n 

Co
un

t

Baseline Week 4 Week 8 Week 12

44.8

26.0
19.0 14.8

65.3

40.4

31.7 26.2

110.1

66.3

50.6
40.9

Inflammatory Non-Inflammatory Total

†

†
††

† †

†

†
†

Figure 2. Lesion Counts (ITT, LOCF, n = 185*)

*Baseline lesion counts missing for 1 patient (ITT, n = 186); †P < .0001 vs baseline, at all post-baseline assessments

-50

-20

-60

-10

-40

-30

-70

0

M
ea

n 
Pe

rce
nt

 C
ha

ng
e

Baseline Week 4 Week 8 Week 12

Inflammatory Non-Inflammatory Total

-38.5

-55.0

-66.2

-34.6

-50.2

-58.7

-38.9

-53.9

-62.6

†

†

†

†

†

†

†

†

†

Figure 3. Percent Reduction in Lesion Count (ITT, LOCF, n = 185*)

*Baseline lesion counts missing for 1 patient (ITT, n = 186); †P < .0001 vs baseline, at all post-baseline assessments

M
ea

n 
To

le
ra

bi
lit

y S
co

re

Baseline Week 4 Week 8 Week 12
n = 175

Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

n = 166 n = 161 n = 165

0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0

1 = Mild

Erythema
Scaling
Dryness
Stinging/Burning

13 (7.8) 0 (0) 4 (2.5) 0 (0) 7 (4.2)
1 (0.6) 0 (0) 4 (2.5) 0 (0) 2 (1.2)
3 (1.8) 0 (0) 1 (0.6) 0 (0) 2 (1.2)

1 (0.6) 12(7.2) 1 (0.6) 1 (0.6) 1 (0.6) 2 (1.2)

18 (10.3)
2 (1.1)
1 (0.6) 1 (0.6)

0 (0)
0 (0)

0 (0)

0 (0)
0 (0)
0 (0)

2 (1.2)

Number and Percent of Subjects with Tolerabiliity Scores of Moderate/Severe at Each Time Point, n (%)

Figure 4. Local Tolerability (Safety population)

NOTE: Tolerability data was only collected at study visits (no tolerability data was collected for weeks 1 through 3).


	FC17PosterGaldermaDelRossoEfficacySafetyGel.pdf