Author(s) : Brigitte Dréno, Vincenzo Bettoli, Falk Ochsendorf, Montserrat Perez-Lopez, Håkan Mobacken, Hugo Degreef, Allison Layton , Department of Dermatology, Hotel Dieu, Place Alexis Ricordeau, 44093 Nantes Cedex 01, France, Azienda Ospedaliera Universitaria Di Ferrara – Arcispedale S. Anna, Sezione di Dermatologia, Corso Giovecca 203, 44100 Ferrara, Italy, Klinikum der Johann Wolfgang Goethe-Universität, Zentrum der Dermatologie und Venerologie (ZDV) Theodor-Stern-Kai 7, D-60590 Frankfurt am Main, Germany, Hospital de la Santa Creu i Sant Pau de Barcelona, Servicio de Dermatología, C/Sant Antoni Maria Claret, 167, 08025 Barcelona, Spain, Department of Dermatology, Sahlgren’s University Hospital, S-413 45 Göteborg, Sweden, University Hospital St Rafaël, Department of Dermatology, Kapucijnenvoer, 33, B3000 Leuven, Belgium, Harrogate and District Foundation Trust, Lancaster Park Road, Harrogate, North Yorks, HG2 7SX, UK.
Summary : In 2003 the European Agency for the Evaluation of Medicinal Products amended the summary product characteristics for oral isotretinoin to standardise information provided from the different countries of the European Community. The Committee for Proprietary Medicinal Products recommended that among others, exclusively severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to “adequate courses” of standard therapy with systemic antibacterials and local therapy should benefit from oral isotretinoin. However, no indication was provided on what were considered adequate courses or the possibility given to use oral isotretinoin as first line treatment. The aims of the present report were: 1) to provide a specialist view on when it is appropriate to introduce oral isotretinoin as a second line therapy for acne, taking into consideration optimum dosage and duration of systemic antibiotics prior to the start of the oral isotretinoin, and 2) to support the use of oral isotretinoin as first line therapy in specific cases for acne in clinical practice. The recommendations are based on an exhaustive literature review as well as on the personal experience of the members of an European panel of acne specialists. The EEP agreed with the decision made by the CPMP that oral isotretinoin should be administered as 2
nd line therapy in those cases of severe acne, which were resistant to or which did not respond successfully to an initial combination regimen with systemic antibiotics and topical treatments (topical retinoids ± benzoyl peroxide). However, the members emphasized that a number of prognostic factors, as well as psychosocial morbidity should be taken into account when choosing the regimen and that these factors may influence the use of oral isotretinoin as first line therapy.
Figure 1 Global Alliance Treatment
Algorithm**.1 Papulopustular acne with some nodular
lesions; †Second course in case of relapse; *Consider
physical removal of comedones. # There was no consensus
on this alternative recommendation. However, in some countries,
azelaic acid prescribing is appropriate practiceBPO: benzoyl
peroxide.** Reprinted from Gollnick H, Cunliffe W, Berson D, Dreno
B, Finlay A, Leyden JJ, Shalita AR, Thiboutot D; Global Alliance to
Improve Outcomes in Acne. Management of acne: a report from a
Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol
2003; 49(1 Suppl): S1-37) with permission from The American Academy
of Dermatology, Inc.
Figure 2 Patients treated successfully with oral
isotretinoin as 1st line therapy. Female patient
presenting with a rapid evolution of inflammatory acne lesion scars
(ice pick).
Figure 3 Patients treated successfully with oral
isotretinoin as 1st line therapy. Male patient with
nodular acne on the face and back causing severe psychological
impact.