Method of administration
Cutaneous use
Dosage regimen
Skinoren Cream should be applied to the affected areas of skin twice daily (mornings and evenings), and rubbed in gently. As a guide 2.5 cm (approx. 0.5 g) of cream is sufficient for the entire facial area. If other areas of acne, in addition to the face require treatment, for example the chest and back, the amount of cream should be adjusted accordingly.
Patients with sensitive skin should be advised to use Skinoren only once a day (in the evening) for the first week of treatment and then proceed to twice daily applications.
Before Skinoren Cream is applied, the skin should be thoroughly cleaned with plain water and dried. A mild skin-cleansing agent may be used.
The duration of use of Skinoren Cream can vary from patient to patient and also depends on the severity of the acne. In general, a distinct improvement becomes apparent after about 4 weeks. To obtain the best results, Skinoren Cream should be used continuously over a period of several months (see Section 5.1 Pharmacodynamic properties).
It is important to continue to use Skinoren Cream regularly over the entire period of treatment. However, in the event of intolerable skin irritation (see Section 4.8
Undesirable effects), the amount of cream per application should be reduced or the frequency of use of Skinoren Cream should be reduced to once a day until the irritation ceases. If required, treatment might have to be temporarily interrupted for a few days.
Additional information on special populations
Paediatric population
Use in adolescents (12 - 18 years of age): dose adjustment is not required when Skinoren Cream is administered to adolescents aged 12 - 18 years.
The safety and efficacy of Skinoren Cream in children below the age of 12 years have not been established.
Geriatric patients
No targeted studies have been performed in patients aged 65 and over.
Patients with hepatic impairment
No targeted studies have been performed in patients with hepatic impairment.
Patients with renal impairment
No targeted studies have been performed in patients with renal impairment.