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Test Results (Accutane)


In the first test, 28 patients with acne conglobata and inflammatory acne took a low dose of isotretinoin (20 mg/kg, 10 mg/kg, or 0.5 mg/kg daily for 6 months). The second test, 11 patients took a very low dose of isotretinoin (2.5 mg to 5 mg per day or 2.5 mg twice a week for 6 months). Both clinical trials involved multiple endpoints, including clinical scaling, lesion counts, counts of follicular filaments (believed to be precursors to lesions), qualitative assessment of sebum using high power, thin layer chromatography, bacterial colonization, patients' feedback of seborrhea levels, two objective measurements of sebum levels (Sebutape and Bentonite clay) and biopsies in order to evaluate the sebaceous glands size and configuration.

Tests presented a huge improvement of the first trial in which the low doses of isotretinoin used revealed considerable improvements in all parameters tested. The numbers of follicular filaments and lesions dropped, as well as levels of bacteria and sebum. Also, it was reported that sebaceous glands shrank.

The second test (ultra-low doses) revealed that efficiency was kept on many of the elements. There were great reduction in numbers of active lesions and follicular filaments as well as objective measures of sebum levels. The patients' ratings of seborrhea improved, and levels of P. acnes on the skin decreased.

Dr. Plewig stated: "The endpoint or the lowest point of a retinoid being effective for the treatment of seborrhea, persistent low grade acne, or maintenance therapy for patients with severe acne probably is around 2.5 mg or 2 mg, or maybe even 1.5 mg".

Dr. Plewig also informed that the ideal patients for low and ultra-low doses of isotretinoin therapy, are individuals with severe acne who were controlled with higher doses and require now a lower-dose maintenance therapy, as well as patients whose facial acne has persisted from adolescence into adulthood and people with sebaceous gland hyperplasia. He added: "Some patients are only concerned about their oiliness. For these I think the low or ultra-low dosage is perfect, and cheap, too".

Supplied by: Study Spotlights