COMPARISON OF 2 ESTRADIOL TRANSDERMAL SYSTEMS (OESCLIM(R)-50 AND ESTRADERM TTS(R)-50) .2. LOCAL SKIN TOLERABILITY

Objectives: The objectives were to compare the local skin tolerability of a matrix-type estradiol transdermal system, Oesclim(R) 50, with th at of the reservoir-type system, Estraderm TTS(R) 50. Methods: Two ran domised studies were performed. In the first study, the modified Draiz e-Shelanski-Jordan method of sensitization was used in an open, parall el-group trial to compare the cutaneous tolerability of repeated appli cations of Oesclim 50(R) with that of Estraderm TTS 50(R) in 24 health y postmenopausal women. The second study was an open, randomised, para llel-group, multi-centre clinical trial involving 283 healthy menopaus al women. A total of 143 women were allocated to treatment with Oescli m 50(R) and 140 to Estraderm TTS(R) 50. The treatment duration was fou r months. Results: The first study showed that the treatments, Oesclim (R) 50 and Estraderm TTS(R) 50, had no sensitizing potential and did n ot induce allergic reactions. In the second study, 4.2% of application s in the Oesclim group provoked reactions compared with 9.5% in the Es traderm group (P < 0.001). Thirty-seven patients (25.9%) treated with Oesclim and 55 patients (39.9%) receiving Estraderm(R) experienced one or more reactions (P < 0.05). Redness and itching were the most frequ ent types of application site reaction in both treatment groups. The d urations of the reactions were significantly shorter in the Oesclim(R) group (P < 0.01), with a higher percentage of durations of less than 1 h and a lower percentage of durations of over 48 h than in the Estra derm TTS(R) 50 group. None of the reactions in the Oesclim(R) group le d to premature removal of the patch, compared with 11 (3.4%) in the Es traderm group (P < 0.05). The number of patients who discontinued trea tment due to application site reactions was one (0.7%) in the Oesclim group and seven (5.1%) in the Estraderm group (P < 0.05). Efficacy and general safety were comparable in the two treatment groups. Conclusio ns: In the first study, neither Oesclim nor Estraderm induced allergic reactions. In the second study, the local skin tolerability of Oescli m was significantly better than that of Estraderm, in terms of the num ber, duration and severity of the application site reactions.