Active Ingredients: Isotretinoin
Most patients should be treated until their skin condition clears and then for a further few months.
Drug interactions with isotretinoin Care should be taken with the following medications: Vitamin-A retinoic acid: side effects are cumulative and could be severe.
Beta-carotene provitamin-A is permitted.
Tetracyclines including doxycycline, minocycline: these could increase the risk of headaches and blurred vision due to raised intracranial pressure.
Warfarin: monitor INR carefully.
What are the side effects and risks of isotretinoin? The longest time of the therapy was 22 months, the shortest — 10 months. Within a 5-year observation period, recurrences were found in 11 7.
Mean time from treatment completion to a relapse was 17. Adverse effects during the therapy were mild and included: cheilitis 66.
Slightly elevated levels of liver enzymes and lipids in serum were found in 20 subjects. The study was done on 50 patients 25 females, 25 males; a half of the group received the above treatment regimen while the other half was given isotretinoin locally only.
The patients were divided into 2 age groups: group I consisted of patients aged 12—20 years while group II — those aged 21—35 years. After a 3-month therapy, an improvement was observed in 90. Four patients did not complete the therapy.
Within a 2-year observation period after the treatment, recurrences occurred in 3. Rademaker et al.
A randomized study with double-blind trial was carried out on 60 patients, aged 25—55 years. All patients underwent a check-up 10 weeks after completing the therapy 45 patients finished the study. The fastest significant reduction in skin lesions was observed within the first 4 weeks of the treatment group I.
A systematic though less dynamic improvement was seen until the 32 nd week of the therapy mean number of skin lesions before the therapy — 11.
A similar, statistically significant reduction in skin lesions was found in group II, however, only in week 20.
Isotretinoin 13-cis-retinoic acid, a first-generation retinoid, influences the basic pathogenic factors for acne: suppresses sebum production, demonstrates comedolytic activity, has direct and indirect anti-inflammatory activity, despite having no antibacterial properties, significantly reduces Propionibacterium acnes population.
The use of isotretinoin in Member States of the European Union, regulated by the Directive of the European Medicine Agency EMA, is approved for severe forms of acne, such as nodular or conglobate acne or acne at risk of scarring.