Open label multi-centre trial on efficacy and tolerability of microionized isotretinion therapy in treatment of moderate to severe acne vulgaris

Bela Shah, Neha Jangid, Aswini A. Naidu


Background: Isotretinion was approved by United States Food and Drug Administration (US FDA) in 1982 for the treatment of severe recalcitrant nodulocystic acne. Its conventional recommended dose has been 0.5-1.0 mg/kg body weight per day for 16-32 weeks, with a maximum cumulative dose of 120 mg/kg. Objective of the study was to assess the efficacy and tolerability of 24 week of once daily micronized isotretinoin therapy in the treatment of moderate to severe acne vulgaris was conducted.

Methods: Total n=580 of patients were included with 249 (43%) male and 331 (57%) females. Patients were assessed at baseline 6, 12 and 24 weeks and 12 weeks post treatment follow-up based on the assessment of severity of acne vulgaris using global acne grading system (GAGS), assessment of improvement in lesion counts, global assessment of overall efficacy by doctor (based on overall assessment) and by patients (based on overall relief in symptoms) and overall assessment of drug tolerability.

Results: In terms of improvement in lesions, excellent results from 4% (22) in week 6th has move to 34% (193) in week 24th. In terms of global efficacy examined by doctors, very effective results i.e. 40% (234) in 12th week has moved to 70% (403) in 24th week. In terms of drug tolerability, excellent results have moved from 119 patients to 190 patients by end of the study.

Conclusions: Hence the micronized isotretinoin therapy had overall satisfactory outcome in the treatment of patients with moderate to severe acne vulgaris (grade 2, 3 and 4).


Low-dose isotretinoin, Acne vulgaris, Efficacy

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Webster GF. Acne vulgaris. BMJ. 2002;325(7362):475-9.

Lanton A. Use of isotretinion in acne. Dermatoendocrinology. 2009;1(3):162-9.

Strauss JS, Leyden JJ, Lucky AW, Lookingbill DP, Drake LA, Hanifin JM, et al. A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne. J Am Acad Dermatol. 2001;45:187-95.

Skin- effectiveness of isotretinion in acne-Cochrane data base. 2018. Available at: Accessed on: 20 August 2020.

Tan J, Desai SBK, Knezevic S. Oral isotretinoin: New developments relevant to clinical practice. Dermatol Clin. 2016;34(2):175-84.

Rao PK, Bhat RM, Nandakishore B, Dandakeri S, Martis J, Kamath GH. Safety and efficacy of low-dose isotretinoin in the treatment of moderate to severe acne vulgaris. Ind J Dermatol. 2014;59(3):316.

Agarwal US, Besarwal RK, Bhola K. Oral isotretinoin in different dose regimens for acne vulgaris: A randomized comparative trial. J Dermatol Venereol Leprol. 2011;77(6):688-94.

Akman A, Durusoy C, Senturk M, Koc CK, Soyturk D, Alpsoy E. Treatment of acne with intermittent and conventional isotretinoin: a randomized, controlled multicentre study. Arch Dermatol Res. 2007;299(10):467-73.

Costa CC, Bagatin E, Martimbianco ALC, da Silva EMK, Lúcio MM, Magin P, Riera R. Oral isotretinoin for acne. Cochrane Database Syst Rev. 2018;11:CD009435.

Bettoli V, Guerra-Tapia A, Herane MI, Piquero-Martin J. Challenges and Solutions in Oral Isotretinoin in Acne: Reflections on 35 Years of Experience. Clin Cosmet Investig Dermatol. 2019;12:943-51.

Tashtoush BM, Jacobson EL, Jacobson MK. UVA is the major contributor to the photodegradation of tretinoin and isotretinoin: implications for development of improved pharmaceutical formulations. Int J Pharm. 2008;352:123-8.

Torok HM, Pillai R. Safety and Efficacy of Micronized Tretinoin Gel (0.05%) in Treating Adolescent Acne. J Drugs Dermatol. 2011;87(6):305-10.

Lucky AW, Sugarman J. Comparison of micronized tretinoin gel 0.05% and tretinoin gel microsphere 0.1% in young adolescents with acne: a post hoc analysis of efficacy and tolerability data. Cutis. 2011;87(6):305-10.

Webster G, Cargill I, Quiring J, Vogelson CT, Slade HB. A combined analysis of two randomized clinical studies of tretinoin gel 0.05% for the treatment of acne. Cutis. 2009;83:146-54.

Lucky AW, Sugarman JL. Comparison of micronized tretinoin gel (0.05%) and tretinoin gel microsphere (0.1%) in subjects aged 10–14 years: a post-hoc analysis of efficacy and tolerability data from two randomized controlled clinical trials. Cutis. 2011;87(6):305-10.