Clinical Evaluation of Roxithromycin in Patients with Acne
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The Journal of
International Medical Research
1996; 24: 109 -114
Clinical Evaluation of
Roxithromycin in Patients with
Acne
H AKAMATSU, S NISHIJIMA, M AKAMATSU, I KUROKAWAAND Y ASADA
Department of Dermatology, Kansai Medical University, Osaka, Japan
On the basis of reports that erythromycin is effective in the
treatment of acne, we investigated whether roxithromycin
(ROM), a new derivative of erythromycin, might also be
effective in treating acne. Roxithromycin was administered
to 30 patients with acne for 8 weeks. General improvement
was assessed 8 weeks after the initiation of the therapy with
a six-graded scale as follows; 1: good improvement, 2:
moderate improvement, 3: slight improvement, 4: no
change, 5: worsening, and 6: no assessment. The percentage
of good or moderate improvement was 73.3%, and that of
good improvement alone was 20.0%. Our results suggest
that ROM is effective in the treatment of acne.
KEY WORDS: ROXITHROMYCIN; ACNE; THERAPY
INTRODUCTION
The first-choice treatment of acne, a chronic manly used because they have strong anti-
inflammatory disease of the sebaceous hair biotic potency against P. aenes' as well as an
follicles of the skin, is an antibiotic against anti-inflammatory effect." - 5 Macrolide anti-
Propionibacterium aenes (P. aenes), a biotics, which have a potent antibacterial
microbe which is harboured in the hair fol- activity against P. aenes' and anti-inflamma-
licles. Tetracyclines have been most com- tory properties.v-" (an effect also observed
109with tetracyclines) have been less frequently tration (MIC) of ROM was determined by the
administered. They have a shorter half-life in medium dilution method, as described by
the blood than tetracyclines, which necessi- the Japanese Society of Chemotherapy.":"
tates more frequent administration of the for each sample of P. acnes.
drug, and potential liver toxicity, which lim- Symptomatic and general improvement
its their long-term use." was assessed 8 weeks after the initiation of
Recently, roxithromycin (ROM) a new the therapy with a six-graded scale as fol-
derivative of erythromycin has been devel- lows; 1: good improvement, 2: moderate
oped. ROM is relatively stable in gastric improvement, 3: slight improvement, 4: no
juice, easily absorbed and efficiently distrib- change, 5: worsening, and 6: no assessment.
uted into tissues. In comparison to erythro- Adverse effects, when present, were pre-
mycin, ROM has a similar antibiotic profile cisely described: symptoms, date of onset,
but has a longer half-life, which enables once grade, circumstance and outcome. Overall
or twice daily adrninistration.P"?" utility of the drug was assessed by a six-
In this report, we investigated the clinical graded scale as follows: 1: very useful, 2:
evaluation of ROM in patients with acne. moderately useful, 3: slightly useful, 4:
equivocal, 5: harmful, and 6: no assessment.
PATIENTS AND METHODS
RESULTS
PATIENTS Data according to types of skin eruption for
Thirty patients with acne (2 male and 28 both dosing regimens combined are shown
female), 14 to 26 years of age, attending for in Fig. 1. The percentages of patients who
treatment at the Department of Dermatology showed good or moderate improvement were
at Kansai Medical University, were enrolled 46.6% for comedo, 50.0% for red papule,
in this study. 57.1 % for pustule, 66.7% for cyst, 25.0% for
nodule and 33.4% for seborrhoea.
STUDY DESIGN The results for general improvement are
Roxithromycin was administered orally for 8 shown in Fig. 2. Of the patients, 73.3%
weeks in a daily dose of either 150 mg (14 showed good or moderate improvement and
patients) or 300 mg (16 patients). No other 20% showed good improvement.
drugs that may have affected the evaluation Improvement ratio according to daily
of the effect of treatment were used. dose is shown in Fig. 3. In the 150 mg group,
71.4% showed good or moderate improve-
MEASUREMENTS ment compared with 75.1% in the 300 mg
The degree of comedo, red papule, pustule, group. For the good improvement category,
cyst, nodule and seborrhoea were evaluated the percentages were 7.1% for the 150 mg
with the following five-graded scale; 0: none, group and 31.3% for the 300 mg group.
1: slight, 2: moderate, 3: severe, and 4: very With regard to adverse effects, slight sto-
severe. mach pain was observed in one patient and
Propionibacterium acnes was isolated moderate nasal bleeding in another. There
from comedones of patients with acne before was no clear connection between these
treatment. All were identified by biochemi- symptoms and the administered drug,
cal tests.":" Minimum inhibitory concen- although symptoms were relieved after dis-
110H Akamatsu, S Nishijima,
M Akamatsu et at
Roxithromycin in
patients with acne
FIGURE 1
o 25 50 75 100%
comedo
(n=30)
o good improvement
~ moderate improvement
red papule ~ slight improvement
(n=30) • no change
pustule D worsening
(n= 28)
cyst
(n=9)
nodule
(n=8)
seborrhoea 41
(n= 24)
Percentage of patients showing symptomatic improvements 8 weeks after initiation of
therapy with roxithromycin, assessed according to type of skin eruption.
FIGURE 2
o 25 50 75 100%
o good improvement
~ moderate improvement
20.0 ~ slight improvement
• no change
o worsening
(n = 30)
Percentage of patients showing general improvement 8 weeks after initiation of
therapy with roxithromycin.
continuation of the drug. Of patients, 80% before treatment. Fourteen strains of P. aenes
found the drug treatment very or moderately were susceptible to ROM below the MIC of
useful (Fig. 4). 0.2 ,ug/ml. Three strains of P. aenes were
Seventeen strains of P. aenes were iso- resistant to ROM. The MIC of these strains
lated from comedones of patients with acne was> 100 ,ug/ml.
111FIGURE 3
o 25 50 75 100%
D good improvement
150 mg ~ moderate improvement
(n = 14)
~ slight improvement
• nochange
D worsening
300 mg
(n = 16)
Percentage of patients showing improvement 8 weeks after initiation of therapy with
roxithromycin, according to daily dose.
FIGURE 4
o 25 50 75 100%
D very useful
~ moderately useful
23.3 E3 slightly useful
• equivocal
D harmful
(n = 30)
Overall utility rating for treatment with roxithromycin.
aenes, but also to the inhibitory effects on
DISCUSSION the production of P. aenes-associated inflam-
The present study showed that ROM is an matory mediators, and therefore on the
effective drug for acne. A daily dose of 150 activity of neutrophil chemotaxis." - 18 Our
mg resulted in only a small percentage of results demonstrated that ROM has a very
patients showing good improvement, indi- strong antibiotic effect against P. aenes.
cating that a daily administration of 300 mg Tetracyclines are the most favoured anti-
may be required for cases with severe biotics for the treatment of acne, although
inflammation. their use requires some caution because of
The efficacy of antibiotics in acne is due possible adverse effects.' Tetracyclines are
not only to the reduction in number of P. chelating agents that bind with divalent cat-
112ions such as calcium and ferrous ions. They With erythromycin, administration
can, therefore, cause developmental disturb- several times daily was required because of
ance of foetal bone and teeth when adminis- its short half-life in the blood. Erythromycin
tered to pregnant woman. Similar abnormali- is, therefore, not the preferred choice for
ties may be observed for children. acne because long-term treatment is needed.
Concurrent intake of calcium-rich foods such In addition, emergence of an erythromycin-
as milk and certain drugs for indigestion resistant strain due to prolonged adminis-
containing divalent metals should be tration has been reported.":"
avoided. The newly-developed macrolide anti-
In addition, the tetracycline, minocycline, biotic, ROM, is useful because it requires
has specific adverse effects including pig- only once- or twice-daily administration,
mentation of skin and mucosa, and vestibu- and is recommended especially for cases
lar disturbances such as nausea, vomiting, where minocycline might cause side effects.
ataxia and vertigo.!" In most cases, these A daily dose of 300 mg may be more ben-
adverse effects are reversible with time after eficial than that of 150 mg, because higher
discontinuation of the drugs. There are some doses are less likely to induce drug-resistant
reports suggesting phototoxity of minocyc- strains owing to faster improvement in the
line, especially in summer. patient.
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15 Esterly NB, Furey NL, Flanagan LE: The 1996: 24: 109 -114
Received for publication 31 August 1995
effect of antimicrobial agents on chemo- Accepted 6 September 1995
taxis. J Invest Dermatol1978; 70: 51- 55. © Copyright 1996 Cambridge Medical Publications
Address for correspondence
DRH AKAMATSU
Department of Dermatology, Kansai Medical University, 10-15, Fumizono-cho, Moriguchi,
Osaka 570, Japan.
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