Consensus Statements on the Use of Novel Formulations of Isotretinoin: A Modified Delphi Process
June 2024 | Volume 23 | Issue 6 | 429 | Copyright © June 2024
Published online May 10, 2024
Paige Kingston BSa, Leon Kircik MDb, Neal Bhatia MDc, James Del Rosso DOd, Seemal R. Desai MDe, Julie C. Harper MDf, Linda Stein Gold MDg, Firas Hougeir MDh, April W. Armstrong MD MPHi
aKeck School of Medicine of University of Southern California, Los Angeles, CA
bIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY
cTherapeutics Clinical Research, San Diego, CA
dJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; Advanced Dermatology and Cosmetic Surgery, Maitland, FL; and Touro University Nevada, Henderson, NV
eDepartment of Dermatology, The University of Texas Southwestern Medical Center, and Innovative Dermatology, Dallas, TX
fDermatology & Skin Care Center of Birmingham, Birmingham, AL
gHenry Ford Hospital, Detroit, MI
hSoutheast Dermatology Specialists, Douglasville GA
iDivision of Dermatology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA
Abstract
Oral isotretinoin remains a mainstay of treatment for severe, recalcitrant nodular acne. Novel formulations of isotretinoin have been developed over the past decade, including lidose isotretinoin and micronized isotretinoin. It is important to understand the differences between isotretinoin formulations to help guide clinical decision-making and selection of isotretinoin therapy. This study aims to provide evidence-based consensus statements regarding the use of novel formulations of isotretinoin for the treatment of moderate-to-severe acne. The Expert Consensus Group consisted of dermatologists with expertise in the treatment of acne. Voting members met in person to conduct a modified Delphi process; a maximum of 2 rounds of voting were conducted for each consensus statement. A total of 5 statements were generated regarding the use of novel formulations of isotretinoin, addressing the efficacy, tolerability, and side effects of novel isotretinoin formulations. All 5 statements achieved agreement with high consensus. The Expert Consensus Group agrees that individualized selection of isotretinoin therapy is important to maximize efficacy and minimize side effects. Compared to generic isotretinoin, micronized isotretinoin may require lower doses to achieve sufficient plasma concentrations. With the increased bioavailability of micronized formulation, there is no need to calculate cumulative dose; instead, the general recommendation with micronized isotretinoin is to treat for at least 5 months, or longer if needed to achieve clearance. Micronized isotretinoin can be taken in the fed or fasted state and has an acceptable safety profile.
J Drugs Dermatol. 2024;23(6):429-432. doi:10.36849/JDD.7971
INTRODUCTION
Oral isotretinoin is a first-line treatment for severe nodular acne and can be considered for the treatment of moderate acne that is treatment-resistant or for the management of acne that is producing scarring or causing significant psychosocial distress.1 Isotretinoin treats the four components of acne pathogenesis: sebum production, hyperkeratinization, Cutibaceterium acnes, and inflammation.2 Adequate treatment with oral isotretinoin leads to a complete and prolonged remission of severe, recalcitrant acne.3-5 However, the bioavailability and efficacy of traditional isotretinoin can vary, as its absorption is highly dependent on food intake.6-7
New formulations of isotretinoin have been developed over the past decade. Lidose isotretinoin, which is encapsulated in a lipid matrix to increase drug absorption, was approved in 2012 for the treatment of severe acne.8-10 In 2019, a novel formulation of micronized isotretinoin was approved for the treatment of severe acne.8 Micronization of isotretinoin reduces the size of the drug particle, thereby increasing the particle surface area and increasing drug solubility, absorption, and bioavailability.11-13 With these advancements, it is important to understand the differences between novel and traditional isotretinoin formulations when selecting isotretinoin therapy and counseling patients.
