ISOTRETINOIN (ROACCUTANE) USAGE - A SOUTH-AFRICAN CONSENSUS GUIDELINE

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 bl ood tests and physician visits have been addressed. Options. Isotretin oin is known to be the treatment of choice for severe acne. Familiarit y with the drug has lowered the threshold for its use in lesser degree s of acne, particularly when scarring is occurring and other options o utlined in the guideline have failed or are either unsuitable or not t olerated. Outcomes. Severe acne causes permanent physical damage and f requently equally severe psychological damage. The correct use of isot retinoin increases the chance of complete cure, thus maximising the ch ance of meeting the patient's expectations. Evidence. Studies have sho wn that the patient may expect the chance of permanent cure to be betw een 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 cum ulative dose of 120 mg/kg body weight during the course at a daily dos e 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 expe rience in the use of isotretinoin therapy for acne, using the current literature as back-up, reached consensus on the contents of the docume nt. The document was presented to the Congress of the South African De rmatology Society in May 1997. It was subsequently sent to all registe red dermatologists in South Africa for comment. Benefits, harm and cos ts. Correct use of isotretinoin will often effect cure and at worst co nsiderably improve acne. Side-effects due to hypervitaminosis A, while almost inevitable, are uncomfortable rather than dangerous. The poten tial for teratogenicity is stressed. Isotretinoin is an extremely expe nsive drug, but studies have shown that it is cost-effective when comp ared 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 clo se 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. V alidation. This guideline is similar to those recommended by other gro ups outside South Africa. It has been scrutinised by all the practisin g dermatologists in the country. It is endorsed by the Medical Associa tion of South Africa. Sponsors. The production of the guidelines was s ponsored by Roche Products (Pty) Ltd, who convened the group's meeting and provided the back-up literature as required. This sponsorship did not influence the activities of the Working Group.