Isotretinoin (roaccutane) usage--a South African consensus guideline. National Dermatology Working Group.

OBJECTIVE

This guideline has been developed in order to recommend the correct and safe usage of isotretinoin (Roaccutane) in the treatment of acne and related conditions. Aspects such as correct dosage related to the patient's weight and the minimal requirement in relation to blood tests and physician visits have been addressed.

OPTIONS

Isotretinoin is known to be the treatment of choice for severe acne. Familiarity with the drug has lowered the threshold for its use in lesser degrees of acne, particularly when scarring is occurring and other options outlined in the guideline have failed or are either unsuitable or not tolerated.

OUTCOMES

Severe acne causes permanent physical damage and frequently equally severe psychological damage. The correct use of isotretinoin increases the chance of complete cure, thus maximising the chance of meeting the patient's expectations.

EVIDENCE

Studies have shown that the patient may expect the chance of permanent cure to be between 60% and 80% at a dose ranging from 0.5 to 1 mg/kg body weight per day for a period of 16-20 weeks. Recent evidence suggests that a cumulative dose of 120 mg/kg body weight during the course at a daily dose of 0.75 mg/kg body weight or greater may be more important than the duration of treatment.

VALUES

The National Dermatology Working Group consisting of 11 consultant dermatologists, all with considerable experience in the use of isotretinoin therapy for acne, using the current literature as back-up, reached consensus on the contents of the document. The document was presented to the Congress of the South African Dermatology Society in May 1997. It was subsequently sent to all registered dermatologists in South Africa for comment.

BENEFITS, HARM AND COSTS: Correct use of isotretinoin will often effect cure and at worst considerably improve acne. Side-effects due to hypervitaminosis A, while almost inevitable, are uncomfortable rather than dangerous. The potential for teratogenicity is stressed. Isotretinoin is an extremely expensive drug, but studies have shown that it is cost-effective when compared with prolonged treatment with other modalities in what is usually a chronic condition.

RECOMMENDATIONS

The optimal dosage recommended is a cumulative dose of 120 mg/kg body weight with a daily dose as close to 1 mg/kg body weight as possible. Isotretinoin is used for severe acne, lesser degrees of acne where scarring is seen, and in patients who do not respond to or cannot tolerate other treatment modalities.

VALIDATION

This guideline is similar to those recommended by other groups outside South Africa. It has been scrutinised by all the practising dermatologists in the country. It is endorsed by the Medical Association of South Africa.