Efficacy and Tolerability of a Topical Erythromycin/Tretinoin Combination Preparation in Acne Treatment: Post-marketing Surveillance Study Involving Over 6500 Patients

J. Kreusch and R. Bextermöller


Curr Med Res Opin. 2000;16(1) 

In This Article

Summary and Introduction

The good efficacy and tolerability of an alcoholic erythromycin/tretinoin solution was confirmed in a multicentre data investigation of over 6500 patients. The mean score for comedones declined clearly from 1.9 to 0.9 during treatment (average duration 70 days). The score for papules and pustules was reduced from 1.6 to 0.5. Overall medical assessment indicated 'very good' to 'good' efficacy in 86.1% of documented cases. Adverse drug reactions during treatment were mostly only very mild and were nearly always the known symptoms of redness, scaling, dryness and itching. Overall assessment of tolerability was 'very good' or 'good' in 88% of cases.

Acne vulgaris is one of the most common skin disorders world-wide. It occurs during puberty with a prevalence of nearly 100% and usually subsides again in early adulthood. Approximately a quarter of all adolescents have marked acne symptoms which are often dismissed by those in social contact with the individual as a cosmetic or hygienic problem. Thus the psychosocial consequences of acne can be a great strain, especially in this age group[1].

The pathogenesis of acne involves numerous important factors, the interaction of these factors causing the outbreak of the skin disorder. In addition to a hormone-related increase in sebum production and disturbed hornification in the sebaceous gland infundibulum, bacterial colonisation with Propionibacterium acnes and a particular type of inflammatory behaviour in the area of the sebaceous glands are involved in the acne process. The interaction of seborrhoea and disturbed hornification leads to the formation of closed and open comedones which may develop into papules, pustules and nodules owing to inflammatory reactions. Acne occurs mainly in areas that have a high concentration of sebaceous glands, such as the face, chest and back.

Modern agents used in the treatment of acne attack the multifactor, pathogenetic chain of acne development at various points. Anti-seborrhoeic, keratolytic, antimicrobial and anti-inflammatory therapeutic principles are the most important ones[2,3].

Mills and Kligman[4] were the first to describe the combined effect of erythromycin and tretinoin compared to the individual components. Combined application of the two active ingredients was seen to be clearly superior. Investigations by Pfannschmidt et al.[5] showed that the irritative effects which may be triggered by tretinoin may be mitigated to a great extent when erythromycin is also applied. These marked advantages led to more intensive research being carried out in this area[6,7,8]. Depending on the concentration and the duration of treatment, the 'tried and tested' peeling agent tretinoin causes loosening of the horny plug in the outlet of the sebaceous glands. Closed comedones open and their contents are expelled. Tretinoin rectifies disturbed hornification in the follicle of the sebaceous gland and prevents formation of new comedones. The release of inflammatory mediators and free fatty acids is reduced. Erythromycin is a macrolide which has proved in the past to be excellent for treating inflammatory forms of acne. It combats the micro-organisms relevant for the pathogenesis of acne (particularly Propionibacterium acnes. In addition to its antibacterial effect, a direct anti-inflammatory effect is attributed to it[9].

The test preparation is a new combination of erythromycin (4%) and tretinoin (vitamin A acid 0.025%) in an ethanol solution with glycerol and copolyvidone (Aknemycin ® Plus, HERMAL). It combines the active principles of the two 'tried and tested' therapeutic agents for acne (comedolysis/antibacterial and anti-inflammatory effect) in one preparation. The 90% ethanol base supports the antimicrobial effect. The excipients added (glycerol and copolyvidone) prevent the skin from drying out.

As part of the marketing authorisation procedure, controlled clinical trials demonstrated the efficacy,safety and tolerability of the combination preparation[10,11]. The aim of this post-marketing surveillance study was to acquire further information on the use of the combination preparation in daily dermatological practice.


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