Comparative efficacy of shampoos containing coal tar (4.0% w/w; Tarmed (TM)), coal tar (4.0% w/w) plus ciclopirox olamine (1.0% w/w; Tarmed (TM) AF) and ketoconazole (2.0% w/w; Nizoral((R))) for the treatment of dandruff/seborrhoeic dermatitis

The therapeutic efficacy acceptability of three scalp shampoo treatments an d a placebo shampoo preparation were compared in two similar double-blind c linical studies in a total of 274 patients with dandruff/seborrhoeic dermat itis. In the first study, a shampoo containing 4.0% w/w coal tar BP (Tarmed (TM)) was compared with placebo (shampoo base without coal tar). In the sec ond study, shampoos containing 4.0% w/w coal tar BP plus 1.0% w/w ciclopiro x olamine (Tarmed(TM) AF) or 2.0% w/w ketoconazole (Nizoral(R)) were compar ed with a placebo shampoo base without coal tar, ciclopirox olamine or keto conazole. The placebo formulations used in the two studies were identical. In both studies, unmedicated shampoo was used for 2 weeks (pretreatment was hout phase), followed by scalp treatment for 4 weeks, then unmedicated sham poo for a further 2 weeks (regression period). Shampooing was carried out t wice-weekly throughout, in accordance with the manufacturers' instructions. Clinical examinations were performed prior to treatment (day 1) and on day s 8, 15, 29 and 43. Subjective assessments of efficacy and acceptability we re recorded by patients on days 1, 8, 15, 29 and 43. The coal tar plus cicl opirox olamine shampoo and the ketoconazole shampoo produced significant im provements in dandruff and seborrhoeic dermatitis during the treatment phas e of the study. The improvements were similar for both treatments, except o n day 29, when the coal tar plus ciclopirox olamine shampoo was associated with a significantly greater reduction in the area of seborrhoeic dermatiti s than the ketoconazole shampoo. In general, the coal tar shampoo containin g only coal tar appeared less effective than the other medicated shampoos. Improvements were sustained during the regression period in the treatment g roups, the mean scores on day 43 for the medicated shampoos were significan tly improved relative to baseline scores for most of the efficacy criteria.