Isotretinoin formulation for acne administered without food may increase patient adherence
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Key takeaways:
- All patients achieved complete clearance of their nodules by week 24.
- There were small, yet significant, increases in erythema, dryness and peeling severity at the beginning of treatment.
Once-daily micronized isotretinoin can be administered without food for the treatment of patients with severe acne vulgaris, allowing for the potential increase of patient adherence, according to a study.
“Due to its poor aqueous solubility, isotretinoin has historically required ingestion with food — specifically a high-fat meal with each dose — to ensure optimal absorption and consistent plasma concentrations of isotretinoin,” James Q. Del Rosso, DO, adjunct clinical professor of dermatology at Touro University Nevada College of Osteopathic Medicine, and Leon H. Kircik, MD, clinical professor of dermatology at Icahn School of Medicine at Mount Sinai, wrote. “This makes patient adherence a concern, particularly in adolescents and young adults, who often exhibit inconsistent eating patterns such as skipping breakfast, and who are most often the recipients of treatment for acne vulgaris.”
Approved for the treatment of severe recalcitrant nodular acne in patients aged 12 years and older, micronized isotretinoin 0.4 mg/kg to 0.8 mg/kg diffused in a lipid carrier system is supposed to be administered in two divided doses daily. However, once-daily dosing is often recommended to increase adherence, although there are limited data to support the efficacy and safety of this practice.
In this pilot study, 24 patients (mean age, 20 years; 58% male; 83% white) aged 12 years and older with severe nodular acne were administered daily micronized isotretinoin 0.4 mg/kg to 0.8 mg/kg without food for 20 weeks.
Results showed that from baseline to week 24, nodular lesion count decreased by a median of six, with all patients achieving complete clearance of their nodules (P < .0001). Additionally, 23 of the 24 participants achieved IGA 0 or 1 by week 24 (P < .0001).
There were also significant reductions in all types of lesions counts, with mean percentage reductions of 97.8% ± 5.7% and 98.4% ± 6.2% in inflammatory and noninflammatory lesion counts, respectively.
The researchers did observe small, yet significant, increases in erythema, dryness and peeling severity at the beginning of treatment. Additionally, two patients experienced three adverse events including COVID-19 and pneumonia; however, these were considered unrelated to treatment. No serious adverse events were reported.
According to the Del Rosso and Kircik, this study supports the administration of once-daily micronized isotretinoin without food for 20 weeks as results showed that the dosage yields high efficacy and safety.
“Once-daily micronized isotretinoin administered without food provides a more convenient dosing regimen and is thereby likely to increase patient adherence to [acne vulgaris] treatment and ultimately improve therapeutic outcomes,” the authors concluded.