Skinoren contains a white, opaque cream. 1 g Skinoren cream contains 0.2 g
(20% w/w) micronized azelaic acid.
The antimicrobial action and a direct influence on follicular hyperkeratosis
are assumed to be the basis for the therapeutic efficacy of
Skinoren in acne.
Clinically, a significant reduction of the colonization density of
Propionibacterium acnes and a significant reduction of the fraction of free
fatty acids in the skin surface lipids is observed.
In vitro and in vivo, azelaic acid inhibits the proliferation of
keratinocytes and normalizes the disturbed terminal epidermal
processes in acne. In the rabbit ear model, azelaic acid accelerates the
comedolysis of tetradecane-induced comedones.
Experimental results demonstrate that azelaic acid exerts a dose- and
time-dependent inhibitory effect on the growth and viability of
The molecular mechanisms by which this is accomplished are not entirely
Currently available data suggest that the main effects of azelaic acid in
the treatment of melasma are brought about by an inhibition of
the DNA synthesis and/or an inhibition of the cellular respiration of the
Azelaic acid penetrates into all layers of human skin after topical
application of the cream.
Penetration is faster into damaged skin than into intact skin. A total of
3.6% of the dose applied is absorbed percutaneously after a single
topical application of 1 g azelaic acid (5 g cream).
A portion of the azelaic acid absorbed through the skin is excreted in
unchanged form with the urine.
The remaining portion is broken down by It-oxidation into dicarboxylic acids
with shorter chain length (C7, C5) which have likewise been
found in the urine.
Dosage and administration
Skinoren should be applied to the affected areas of skin twice a day
(morning and evening) and rubbed gently into the skin.
Before Skinoren cream is applied, the skin should be thoroughly cleaned with
clear water, or if applicable, a mild skin-cleansing agent.
It is important to continue to use Skinoren regularly over the entire period
The duration of use of Skinoren can vary from patient to patient and also
depends on the severity of the acne. In patients with acne, in
general, a distinct improvement becomes apparent after about 4 weeks. To
obtain the best results, however, Skinoren should be used
regularly over several months. However, Skinoren should not be used
continuously for more than 12 months at any time.
The amount of Skinoren to be applied will depend on the size of the affected
area. As a guide, a daily dose of approximately 2.5cm/1inch of
cream is sufficient for the entire facial area. Excessive amounts of cream
must be avoided.
In the event of excessive irritation of the skin (see "Side effects"), the
amount of cream per application should be reduced or the frequency
of use of Skinoren should be reduced to once a day until the irritation
ceases, or the treatment should be temporarily interrupted for a few
In clinical studies, most frequently observed side effects included
application site burning, application site pruritus, and application site
Frequencies of side effects observed in clinical studies and given in the
table below are defined according to the MedDRA frequency
Very common (≥1/10),
Common (≥1/100 to <1/10),
Uncommon (≥1/1,000 to <1/100),
Rare (≥1/10,000 to <1/1,000),
Very rare (<1/10,000), not known (cannot be estimated from the available
System organ class
application site pain,
application site dryness,
application site irritation
application site ulcer
Generally, local skin irritation
regresses in the course of treatment.
Rash has been reported rarely in post-marketing surveillance.
Worsening of asthma in patients treated with azelaic acid has been reported
rarely during postmarketing surveillance (the frequency is not (known).
Hypersensitivity to any ingredient of the cream, in particular propylene
Skinoren is intended for external use only. Findings from animal experiments
show that vomiting may occur after ingestion of large
amounts. No organotoxic changes are likely though no human data on
overdosage are available.
Results from acute toxicity studies do not indicate that any risk of acute
intoxication is to be expected following a single dermal application of an
overdose (application over a large area under conditions favourable to
absorption) or inadvertent oral ingestion.
Special warnings and special precautions for use
For external use only.
Care must be taken when using Skinoren cream to avoid contact with the eyes,
mouth and other mucous membranes, and patients should be instructed
accordingly. In the event of accidental contact, the eyes, mouth and/or
affected mucous membranes should be washed with large amount of water. If
eye irritation persists, patients should consult a physician. The hands
should be washed after each application of the Skinoren cream.
Benzoic acid is mildly irritant to the skin, eyes and mucous membranes.
Propylene glycol may cause skin irritation.
Interaction with other medicinal products and other forms of interaction
None so far known.
Pregnancy and lactation
There are no adequate and well-controlled studies of topically administered
azelaic acid in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with
respect to pregnancy, embryonal/foetal development, parturition or postnatal
It is advisable to avoid Skinoren cream during pregnancy unless the benefit
outweighs the risk.
It is not known if azelaic acid is secreted in human milk in vivo. However
an in vitro equilibrium dialysis experiment demonstrated that passage of
drug into maternal milk may occur. But the distribution of azelaic acid into
maternal milk is not expected to cause a significant change from baseline
azelaic acid levels in the milk since azelaic acid is not concentrated in
milk and less than 4% of topically applied azelaic acid is systemically
absorbed not increasing endogenous azelaic acid exposure above physiological
levels. However, Skinoren cream should not be used by lactating woman unless
the benefit outweighs the risk.
Store below 30°C.
Store all drugs carefully and keep them out of reach of children.
Dosage form and packaging
Tubes with 30 g cream