Full text of DOI:10.2165/00044011-200222070-00006

Clin Drug Invest 2002; 22 (7): 455-462
1173-2563/02/0007-0455/$25.00/0
ORIGINAL RESEARCH ARTICLE
© Adis International Limited. All rights reserved.
A Multicentre, Double-Blind,
Parallel-Group Study to Evaluate
3% Erythromycin/5% Benzoyl Peroxide
Dual-Pouch Pack for Acne Vulgaris
Terry Jones,1 Leslie Mark,2 Eugene Monroe,3 Jonathan Weiss4 and Sharon Levy5
1
2
3
4
5
J&S Studies, Inc., Bryan, Texas, USA
Skin Surgery Medical Group, San Diego, California, USA
Advanced Healthcare SC, Milwaukee, Wisconsin, USA
Department of Dermatology, Emory University School of Medicine, Atlanta, Georgia, USA
Dermik Laboratories, Berwyn, Pennsylvania, USA
Objective: The combination of erythromycin and benzoyl peroxide has proven
to be a well-tolerated and effective topical treatment for acne vulgaris. A novel
3% erythromycin/5% benzoyl peroxide formulation provides a single unit-dose
of erythromycin and benzoyl peroxide from a dual-pouch package and eliminates
the need for pharmacist compounding and refrigeration. This study assessed the
tolerability and efficacy of this formulation in patients with acne vulgaris.
Abstract
Design and patients: Multicentre, randomised study in 223 patients with
moderate to moderately severe acne who received 3% erythromycin/5% benzoyl
peroxide via the dual-pouch package or matching vehicle control for 8 weeks.
Results: Active treatment was significantly more effective than vehicle control
in reducing total number of acne lesions (31.9 and 23.1, respectively; p = 0.004)
and the percentage reduction of inflammatory acne lesions (69.2 and 48.1%,
respectively; p = 0.001) from baseline to week 8. Statistical significance for these
parameters was observed within 2 weeks and continued to study endpoint. At
week 8, treatment success was demonstrated in a significantly greater proportion
of patients in the active treatment group (34.8%) compared with the vehicle
control group (14.4%; p < 0.001). No treatment-related serious adverse events
were reported. The most common adverse event was dry skin, which occurred in
12.5 and 5.4% of patients administered active treatment or vehicle, respectively.
Conclusion: This novel formulation was demonstrated to be well tolerated and
effective in the treatment of acne vulgaris. The 3% erythromycin/5% benzoyl
peroxide dual-pouch pack is an alternative to the currently marketed topical gel
for patients with moderate to moderately severe acne vulgaris. This combination
antimicrobial product provides an innovative unit-dose delivery system and
offers the consumer more convenience by eliminating the need for pharmacist
compounding and refrigeration.

456
Jones et al.
Acne vulgaris is a disease of the sebaceous folli-
10-week study involving 165 patients. The inves-
tigators found the combination product was more
effective for pustular and papular lesions than any
of the other treatments. The most dramatic effect
was observed with combined inflammatory lesions
(papules and pustules).[8] This earlier formulation
requires pharmacist compounding and refrigera-
tion to maintain stability, which may be inconve-
nient for the patient. Therefore, a modification of
the original formulation and packaging has been
developed. This novel formulation contains 6%
erythromycin gel and 10% benzoyl peroxide gel,
each individually packaged in a dual-pouch unit-
dose pack. When the entire contents of this dual-
pouch pack are mixed in the patient’s palm after
extrusion, a single dose of 3% erythromycin and
5% benzoyl peroxide is formed. This novel dual-
pouch pack does not require compounding by the
pharmacist or refrigeration and has the added
benefit of convenient, unit-dose packaging. This
current study compared the efficacy and tolerabil-
ity of 3% erythromycin/5% benzoyl peroxide dual-
pouch pack (EBP) [Dermik Laboratories, Berwyn,
PA] with its matching vehicle control (VC) for the
treatment of acne vulgaris.
cles, primarily occurring on the face, chest, and
back.[1] It has been estimated that acne vulgaris af-
fects between 40 and 50 million individuals in the
United States.[2,3] Acne generally begins in ado-
lescence but is not limited to young adults; ap-
proximately 85% of all adolescents aged 12 to 24
years experience some degree of acne.[1,4] The dis-
ease is not life-threatening, although young adults
and adolescents may experience severe psychoso-
cial effects, often deeper and more disastrous than
the blemishes on the cutaneous surface.[5,6] Lasek
and Chren reported that acne vulgaris causes emo-
tional effects similar to those of psoriasis and ad-
versely affects the overall quality of life in these
patients.[7]
The basic cause of acne remains unknown,
although the interaction of four factors has been
implicated in its pathophysiology. These include
increased sebum production, abnormal keratinisa-
tion processes, proliferation of Propionibacterium
acnes, and inflammation caused by sebum and
chemotactic factors generated by P. acnes.[1,5]
Acne may initially develop as non-inflammatory
lesions in pilosebaceous follicles. When the
follicle wall is disrupted, inflammatory lesions
develop, including papules, pustules, nodules and
cysts. The first step in lesion management is to
correctly classify acne severity, since therapy must
be individualised to the fluctuating severity of this
disorder.[1,5] While severe acne may require isotret-
inoin therapy, mild to moderately severe inflamma-
tory acne may be treated by topical agents. Topical
agents include antibiotics, such as erythromycin
or clindamycin, benzoyl peroxide, and various
forms of retinoids.[1,6] Synergistic combinations,
including retinoids/antimicrobials or erythromy-
cin/benzoyl peroxide, may also be used.[1]
Patients and Methods
Study Design and Treatment
This multicentre, randomised, double-blind,
parallel-group study enrolled 223 patients with
moderate to moderately severe acne vulgaris at
four study centres. During this 8-week trial,
112 patients were randomised to receive EBP and
111 patients were randomised to matching VC.
Patients were randomised to treatment regimens in
:
a ratio of 1 1. After washing the face, patients
were instructed to apply the entire contents of 1
unit in a thin layer to the entire face twice daily
(morning and evening). Patients were taught to
squeeze the entire contents of the package into the
palm of the hand and blend together for approxi-
mately 5 seconds prior to application. The first
application was performed under direct supervi-
sion at the study site.
The tolerability and efficacy of combination
erythromycin/benzoyl peroxide have been estab-
lished for a number of years.[8-10] In 1983, Chalker
and colleagues compared the tolerability and
efficacy of combination 3% erythromycin and 5%
benzoyl peroxide with that of 3% erythromycin
gel, 5% benzoyl peroxide gel and vehicle during a
© Adis International Limited. All rights reserved.
Clin Drug Invest 2002; 22 (7)

Erythromycin/Benzoyl Peroxide Dual Pack for Acne
457
Baseline evaluations included a Physician’s
Global Acne Severity Score, comedo counts,
papule/pustule counts, cyst counts and oiliness
scores. At each follow-up visit, scheduled at 2, 4,
6 and 8 weeks, facial lesions were counted and
the Physician’s Global Acne Severity Score
was obtained to determine comparative efficacy.
The Physician’s Global Acne Severity Score, the
physician’s comprehensive evaluation of the
patient’s overall acne condition at the time of eval-
uation, was based on number of lesions and overall
acne condition, including lesion size, overall de-
gree of inflammation, general facial erythema, and
skin condition. Patients scored a 0 (clear; no in-
flammatory lesions), 1 (comedones, some small in-
flammatory lesions, minimal erythema), 2 (come-
dones, moderate number of small inflammatory
lesions, erythema increasing), 3 (numerous come-
dones, papules, and pustules with larger inflamed
lesions, erythema pronounced), or 4 (severe or cys-
tic acne; excluded from study) based on acne se-
verity. Oiliness was ranked as 0 (none), 1 (mild;
limited area), 2 (moderate; entire face), or 3
(severe; requiring removal more than once per
day). At study conclusion, the Patient’s Global Im-
provement Score allowed patients to rank their
overall improvement as 3 (much better), 2 (better),
1 (somewhat better), 0 (no change) or worse.
Patients also rated treatment acceptability at the
final study visit. The determination of relative
efficacy was based on the summaries of the results
of the last week (week 8).
Study Participants
Male and female patients aged ≥13 years with
moderate to moderately severe acne were eligible
for study enrolment. Eligible patients had an over-
all acne severity score ≥1.5 on the Physician’s
Global Acne Severity Scale, 15 to 80 inflammatory
lesions, 20 to 140 comedones, and ≤2 nodules or
cysts measuring greater than 5mm. The comedo
count did not include the nasal and nasolabial fold
area. Discontinuation of treatment with systemic
antibiotics known to affect acne and systemic
corticosteroids 4 weeks prior to study enrolment
was required, as was discontinuation of oral
retinoids 6 months prior to enrolment. A 2-week
washout period was required for topical antibiotics
and/or anti-acne medication, topical cortico-
steroids, and topical retinoids. Patients were ex-
cluded if they were either pregnant or nursing, had
beards or long sideburns, had cystic acne, or had
any other diseases affecting their condition or
interfering with treatment evaluation.
Efficacy and Tolerability Evaluations
The primary efficacy evaluations were lesion
reductions from baseline and treatment success.
Lesion reductions from baseline included inflam-
matory lesions, comedones and total lesions
(inflammatory and comedones). Patients who
achieved treatment success were defined as those
patients with a score of 0 or 0.5 on the Physician’s
Global Acne Severity Scale at the end of the study.
Secondary efficacy evaluations included Physi-
cian’s Global Acne Severity Scores, facial oiliness
scores, Patient Global Improvement Scores, and
patient treatment acceptability. Tolerability evalu-
ations were based on the incidence and severity of
adverse events. Adverse events of all types, includ-
ing those possibly related to treatment and those
affecting the skin, were summarised by treatment
group. The intent-to-treat population included all
patients randomised to active treatment or VC.
Unused medication was retrieved at each visit,
and a study drug supply sufficient to last until the
patient’s next visit was dispensed. Compliance was
assessed by counting the number of unused units
of study medication returned by the patients and
recording missed doses.
This study was performed in accordance with
the principles stated in the Declaration of Helsinki
and with all Food and Drug Administration regu-
lations. Local institutional review boards approved
the study protocol and all patients provided written
informed consent prior to study enrolment.
© Adis International Limited. All rights reserved.
Clin Drug Invest 2002; 22 (7)

458
Jones et al.
Statistical Analysis
OVA and CMH tests. A p-value <0.05 was consid-
ered statistically significant.
Lesion reduction counts and global acne se-
Results
verity scores were fit by analysis of co-variance
models, with treatment group and site factors and
a baseline co-variate. A term for the treatment by
investigator interaction was included in the model
if a preliminary evaluation found p < 0.10 for the
interaction effect. The proportion of patients in
each treatment group with successful treatment
outcome and proportions indicating treatment
acceptability were compared between treatments
based on the Cochran-Mantel-Haenszel (CMH)
test stratified by study site. The analysis of variance
(ANOVA) model for patient evaluations of global
improvement included effects of investigator and
study site and, if a preliminary evaluation found p
< 0.10, the site by investigator interaction. Facial
oiliness scores were also compared between treat-
ments based on the CMH test stratified by study
site. The percentage reductions from baseline were
evaluated within each treatment group using the
Wilcoxon test. Patient demographics and baseline
acne severity measures were compared between
treatment groups and among study sites using AN-
Patient Characteristics
Demographic patient characteristics at baseline
are summarised in table I. Some 49.8% of patients
in the intent-to-treat population were female, and
the average age was 18.5 years. The average dura-
tion of acne was 4.8 years, and 74% had used a
previous acne treatment. There were no significant
differences in patient characteristics between the
EBP and VC groups; however, there was a rela-
tively higher ratio of white to black patients (8:1)
in the EBP group compared with the vehicle group
(5:1). No differences were observed between the
EBP and VC groups with regard to baseline global
severity, lesion counts or oiliness score frequencies
(table II).
Efficacy
At endpoint, intent-to-treat patients in the EBP
group experienced significantly greater total lesion
reductions from baseline (p = 0.004), significantly
greater inflammatory lesion reductions from base-
Table I. Demographic and patient characteristics in the intent-to-treat population
Characteristic
EBP (n = 112)
18.7 6.2
VC (n = 111)
18.2 5.4
All patients (n = 223)
18.5 5.8
Age [y (mean SD)]
Gender [n (%) of patients]
Female
57 (50.9)
55 (49.1)
54 (48.6)
57 (51.4)
111 (49.8)
112 (50.2)
Male
Race [n (%) of patients]
White
94 (83.9)
12 (10.7)
3 (2.7)
82 (73.9)
18 (16.2)
1 (0.9)
176 (78.9)
30 (13.5)
4 (1.8)
Black
Asian
Hispanic
3 (2.7)
10 (9.0)
13 (5.8)
Complexion [n (%) of patients]
Fair
51 (45.5)
44 (39.3)
17 (15.2)
4.9 4.8
50 (45.0)
38 (34.2)
23 (20.7)
4.6 4.6
101 (45.3)
82 (36.8)
40 (17.9)
4.8 4.7
Medium
Dark
Acne duration [y (mean SD)]
Previous therapy [n (%) of patients]
Yes
No
87 (77.7)
25 (22.3)
78 (70.3)
33 (29.7)
165 (74.0)
58 (26.0)
EBP = 3% erythromycin/5% benzoyl peroxide dual-pouch pack; SD = standard deviation; VC = vehicle control.
© Adis International Limited. All rights reserved.
Clin Drug Invest 2002; 22 (7)

Erythromycin/Benzoyl Peroxide Dual Pack for Acne
459
Table II. Mean baseline acne characteristics and efficacy variables in the intent-to-treat population
EBP (n = 112)
VC (n = 111)
Primary variables (mean SD)
Total lesion count
72.4 31.0
31.1 15.7
41.3 26.0
71.5 25.5
29.3 11.7
42.2 21.4
Inflammatory lesion count
Comedo count
Secondary variables (mean SD)
Physician’s Global Acne Severity Scorea
Facial oiliness scoreb
2.1 0.5
1.6 0.6
2.1 0.5
1.7 0.7
a
0 = clear; 1 = comedones, small inflammatory lesions, minimal erythema; 2 = comedones, moderate number of small inflammatory
lesions, increasing erythema; 3 = numerous comedones, larger inflamed lesions, pronounced erythema; 4 = severe/cystic acne.
b
0 = none; 1 = mild; 2 = moderate; 3 = severe.
EBP = 3% erythromycin/5% benzoyl peroxide dual-pouch pack; SD = standard deviation; VC = vehicle control.
Table III. Efficacy evaluations at week 8 (last week of study) in the intent-to-treat population
EBP (n = 112)
VC (n = 111)
p-Valuea
Least squares mean reduction from baseline in
Total lesions
31.9
16.5
15.2
34.8
1.2
23.1
9.6
0.004
Inflammatory lesions
<0.001
0.347
Comedones
13.3
14.4
1.6
Treatment success (% of patients)b
Mean Physician’s Global Acne Severity Scorec
Mean facial oilinessd
<0.001
<0.001
0.026
0.7
0.8
Patient-rated
Improvement (mean)e
2.0
1.6
0.001
0.004
Acceptability (% of patients)
88.2
72.5
a
b
Treatment contrasts using analysis of variance and Cochran-Mantel-Haenszel analyses.
Defined as patient at endpoint with Physician’s Global Acne Severity Score of 0 (clear) or 0.5 (sparse comedones with very few or no in-
flammatory lesions present).
c
0 = clear; 1 = comedones, small inflammatory lesions, minimal erythema; 2 = comedones, moderate number of small inflammatory le-
sions, increasing erythema; 3 = numerous comedones, larger inflamed lesions, pronounced erythema; 4 = severe/cystic acne.
d
e
0 = none; 1 = mild; 2 = moderate; 3 = severe.
−1 = worse; 0 = no change; 1 = somewhat better; 2 = better; 3 = much better.
EBP = 3% erythromycin/5% benzoyl peroxide dual-pouch pack; VC = vehicle control.
line (p < 0.001), and demonstrated a significantly
greater proportion of treatment success than
patients using VC (p < 0.001) [table III]. Patients
using EBPexperienced significantly greater reduc-
tions in inflammatory lesions from baseline at
weeks 2, 4, 6 and 8 (p ≤ 0.002) [figure 1]. At week
8, patients in the EBP and VC groups experienced
a 69.2 and 48.1% reduction in inflammatory lesion
counts from baseline, respectively. Treatment suc-
cess, defined by Physician’s Global Acne Severity
Scores of 0 or 0.5, was significantly higher by
week 4 in the EBP group compared with the VC
group and continued through the duration of the
study (p ≤ 0.02) [figure 2]. Comedo reductions
from baseline were not significantly different be-
tween groups, although a more favourable trend in
comedo reduction was observed in patients treated
with EBP compared with VC.
At the end of the study, results of the secondary
variables, including the Physician’s Global Acne
Severity Score, facial oiliness and patient-rated
global improvement, all reflected the greater effi-
cacy of EBP over VC (table III). The Physician’s
Global Acne Severity Scores were significantly
© Adis International Limited. All rights reserved.
Clin Drug Invest 2002; 22 (7)

460
Jones et al.
using EBP and 56% of those using VC rated global
improvement better or much better. The active
treatment was associated with significantly greater
treatment acceptability compared with the VC
(p = 0.006).
EBP
VC
80
70
60
50
40
30
20
10
**
**
**
*
Tolerability
No treatment-related serious adverse events
were reported during the study. One patient in the
VC group discontinued the study prematurely be-
cause of dryness and itching experienced during
the first 2 weeks of treatment. Nineteen patients in
the EBP group and 10 patients in the VC group
reported at least one treatment-related adverse
event. The most frequent adverse event was dry
skin, reported in 14 (12.5%) patients receiving EBP
and six (5.4%) patients using VC. Other treatment-
related adverse events included application site re-
actions (3.6 and 1.8% of EBP and VC recipients,
respectively) and pruritus (0.9 and 1.8% of EBP
and VC recipients, respectively) [table IV]. Over-
all, EBP treatment was considered safe and well
tolerated.
0
Baseline
2
4
6
8
Treatment duration (wk)
Fig. 1. Percentage of inflammatory lesion reduction from base-
line by treatment week.
* p = 0.002 vs vehicle control, ** p < 0.001 vs vehicle control.
EBP = 3% erythromycin/5% benzoyl peroxide dual-pouch pack;
VC = vehicle control.
EBP
VC
40
35
**
30
25
20
15
*
*
Discussion
10
5
The results of this 8-week study clearly demon-
strated that twice-daily treatment with EBP is more
effective than VC in patients with moderate to
moderately severe acne. Patients in the EBP group
had significantly greater total lesion reductions
from baseline, and a significantly greater propor-
tion of EBP recipients experienced treatment
success compared with patients in the VC group.
As early as week 2, statistically significant reduc-
tions were observed in inflammatory and total
lesions and global severity. The difference in the
0
Baseline
2
4
6
8
Treatment duration (wk)
Fig. 2. Percentage of acne patients (intent-to-treat population)
with treatment success (score of 0 or 0.5 on the Physician’s
Global Acne Severity Scale).
* p ≤ 0.021 vs vehicle control (based on Cochran-Mantel-
Haenszel, stratified by site), ** p < 0.001 vs vehicle control
(based on Cochran-Mantel-Haenszel, stratified by site).
EBP = 3% erythromycin/5% benzoyl peroxide dual-pouch pack;
VC = vehicle control.
Table IV. Incidence of most commonly reported treatment-related
adverse events [n (%) of patients]
lower in the EBP group compared with the VC
group at weeks 2, 4, 6 and 8 (all p ≤ 0.001). Facial
oiliness scores were also significantly lower in
the EBP group versus the VC group at week 2
(p = 0.005), week 4 (p = 0.014), and week 8 (p =
0.026). At the conclusion of the study, 71% of those
EBP (n = 112)
14 (12.5)
4 (3.6)
VC (n = 111)
6 (5.4)
Dry skin
Application site reaction
Pruritus
2 (1.8)
1 (0.9)
2 (1.8)
EBP = 3% erythromycin/5% benzoyl peroxide dual-pouch pack;
VC = vehicle control.
© Adis International Limited. All rights reserved.
Clin Drug Invest 2002; 22 (7)

Erythromycin/Benzoyl Peroxide Dual Pack for Acne
461
proportion of patients with treatment success was
observed as early as week 4. Patients using EBP
had significantly lower oiliness scores at weeks 2,
4 and 8 compared with VC. Although these scores
were based solely on visual inspection, they pro-
vide data on a parameter often overlooked in acne
clinical trials. Numerically better reductions from
baseline in facial comedones were observed in
patients using EBP, indicating that EBP treatment
has some degree of comedolytic activity. Global
improvement and treatment acceptability as rated
by the patients at endpoint were significantly more
favourable in the EBP group compared with the
VC group. EBP was well tolerated and was associ-
ated with a low incidence of treatment-related ad-
verse events. The most frequently observed ad-
verse event, dry skin, occurred in 12.5% of the EBP
group and 5.4% of the VC group. Application site
reactions and pruritus occurred infrequently.
The novel formulation and packaging of EBP
are beneficial in several ways. The unit-dose pack-
aging allows the patient to extrude a single dose of
each drug from the dual pouch and mix the gels just
prior to application, eliminating the need for phar-
macist compounding. Because the packaging sys-
tem eliminates the requirement for refrigeration,
EBP is more convenient to use than the cur-
rently marketed formulation, which may be dif-
ficult for patients to use while travelling. The new
formulation and innovative packaging allow more
flexible medication storage and lengthened shelf-
life for the consumer and may improve patient
compliance, resulting in improved outcomes.
Patients treated with EBP for 8 weeks experi-
enced a 69.2% geometric mean reduction in in-
flammatory lesions. This finding is important,
especially when compared with results from stud-
ies evaluating other topical medications in similar
patient populations. In one 12-week study, the
efficacy and tolerability of adapalene gel 0.1%
were compared with tretinoin gel 0.025% for
the treatment of patients with acne vulgaris.[11]
Although adapalene gel produced numerically
greater lesion reductions than tretinoin gel as early
as 2 weeks following treatment, statistical differ-
ences between the two treatments were not noted
until week 12. The mean percentage reduction in
total lesions among patients treated with adapalene
gel 0.1% and tretinoin gel 0.025% was 49 and
37%, respectively, at week 12 (p < 0.01).[11]
Furthermore, following 12 weeks of treatment
application of adapalene gel 0.1%, patients expe-
rienced a 48% reduction in inflammatory lesions
compared with a 38% reduction in patients receiv-
ing tretinoin gel 0.025% (p < 0.06).[11]
Comparatively, the reduction in inflammatory
lesions observed in EBP-treated patients is an
important finding particularly because few topical
acne medications achieve a reduction in inflamma-
tory lesions of this magnitude. In addition, signif-
icant (p ≤ 0.002) reductions were evident follow-
ing 2 weeks of treatment.
Topical agents such as benzoyl peroxide and
topical antibiotics have important roles in the treat-
ment of patients with mild to moderate acne. These
agents are convenient and effective and are not
associated with the systemic adverse effects ob-
served with oral agents [e.g. gastrointestinal ef-
fects (oral erythromycin); central nervous system
effects (tretinoin)].[12] Benzoyl peroxide has
potent bactericidal activity against P. acnes and ef-
fectively treats inflammatory papules and pustules.
Free fatty acid levels, involved in the formation of
comedones, also decrease with use.[12] Erythromy-
cin and clindamycin are the most commonly used
topical antibiotics for treating moderate acne.
These agents reduce P. ac ne s colonisation on the
skin surface.[12] Both have similar efficacy when
used alone and exert anti-inflammatory as well as
antibacterial effects.[13,14]
Studies indicate that the combination of 3%
erythromycin and 5% benzoyl peroxide is more ef-
fective than either of the two agents alone in treat-
ing acne vulgaris.[1,8] In one study, the combination
of 3% erythromycin and 5% benzoyl peroxide was
more effective than either topical 3% erythromy-
cin or 5% benzoyl peroxide alone at reducing
both pustules and papules and significantly re-
duced inflammatory lesions (papules and pus-
tules) at weeks 4, 6, 8 and 10 compared with vehi-
© Adis International Limited. All rights reserved.
Clin Drug Invest 2002; 22 (7)

462
Jones et al.
cle gel, 3% erythromycin, and 5% benzoyl perox-
ide.[8] In addition to their independent mechanisms
(i.e. the keratolytic effect of benzoyl peroxide and
the antibacterial effect of erythromycin), several
mechanisms have been proposed for the efficacy
of the combined regimen. Benzoyl peroxide may
‘loosen’ the stratum corneum, thereby allowing a
greater degree of erythromycin penetration.[8] The
combination product also may prevent the emer-
gence of resistance to erythromycin.[8,12]
Harkaway and colleagues reported that benzoyl
peroxide alone, or in combination with erythro-
mycin, prevented resistant strains of propioni-
bacterium and staphylococci in patients with
acne.[10,15] Because benzoyl peroxide kills the
bacteria by direct toxicity, resistance of P. acnes to
benzoyl peroxide has not been reported. Results of
a study by Eady and colleagues suggest that the
combination of 5% benzoyl peroxide and 3%
erythromycin may prevent the emergence of
erythromycin-resistant variants and reduce the
number of resistant organisms on the skin of
patients with acne.[10] A later study demonstrated
significant clinical improvements in patients with
high numbers of erythromycin-resistant P. acnes
prior to treatment.[1,9]
Acknowledgements
This work was sponsored by Dermik Laboratories,
Berwyn, Pennsylvania, USA.
References
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9. Eady EA, Bojar RA, Jones CE, et al. The effects of acne
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11. Shalita A, Weiss JS, Chalker DK, et al. A comparison of the
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12. Kaye ET. Topical antibacterial agents. Infect Dis Clin North Am
2000; 14: 321-39
Conclusion
13. Eady EA, Cove JH, Joanes DN, et al. Topical antibiotics for the
treatment of acne vulgaris: a critical evaluation of the litera-
ture on their clinical benefit and comparative efficacy. J
Dermatol Treat 1990; 1: 215-26
14. Plewig G, Schopf E. Anti-inflammatory effects of antimicrobial
agents: an in vivo study. J Invest Dermatol 1975; 65: 532-6
15. Harkaway KS, McGinley KJ, Foglia AN, et al. Antibiotic resis-
tance patterns in coagulase-negative staphylococci after treat-
ment with topical erythromycin, benzoyl peroxide, and
combination therapy. Br J Dermatol 1992; 126: 586-90
The results of this study demonstrated a clear
benefit for patients with moderate to moderately
severe acne vulgaris who use the EBP combination
therapy. The new formulation and innovative pack-
aging are more convenient for the patient and elim-
inate the need for pharmacist compounding and re-
frigeration by the patient. This single-dose system
offers the benefit of fast-acting, dual-antimicrobial
therapy, provides a well tolerated and effective op-
tion for the treatment of moderate acne, and may
lead to better patient compliance.
Correspondence and offprints: Dr Sharon Levy, Dermik
Laboratories, 1050 Westlakes Drive, Berwyn, Pennsylvania
19312, USA.
E-mail: Sharon.Levy@Aventis.com
© Adis International Limited. All rights reserved.
Clin Drug Invest 2002; 22 (7)