Correspondence Mauricio Goihman-Yahr, M.D., Editor Jet International PO Box 02000 Miami, FL 33102
Trimethoprim-Polymyxin B Sulfate Cream Versus Fusidic Acid Cream in the Treatment of Pyodermas: An Update To the Editor: The interim results of a double-blind study comparing trimethoprimpolymyxin B sulfate (TP) cream versus fusidic acid cream in the treatment of superficial bacterial infection of the skin (SBIS) were published after data from 100 patients had been studied.' We would like to update that report by presenting the full results ofthe study. The study protocol has been previously described.' Two hundred fifty patients (225 men and 25 women) with a clinical diagnosis of SBIS were entered into the study, with equal numbers allocated to each treatment group. The majority of cases were diagnosed as secondarily infected scabies (82%), with other diagnoses including impetigo and secondarily infected insect bites, eczema/dermatitis, and traumatic abrasions. Data from 237 patients were available for analysis and the results are summarized in Table 1. No significant differences between treatments were found at the first follow-up assessment at day 8. At the final follow-up assessment (day 15) comparison ofthe two treatments showed that a significantly higher proportion of patients given TP cream had scores recorded as zero for the signs of tenderness and infiltration/induration (p < 0.05, Fisher's exact test). In addition, all other efficacy trends at day 15 were in favor ofthe TP group. The percentage of patients showing significant improvement (2:50%) was 87% for TP cream and 74% for fusidic acid. Two adverse reactions of a minor nature were reported during the study period (one TP and one fusidic acid).
The final results of this study in 250 (237 evaluable) patients confirm the previously reported interim results from the first 100 (87 evaluable) patients. These results show that TP cream effectively reduces the clinical signs and symptoms of SBIS, and that its use is associated with a low incidence of adverse effects. The efficacy trends in favor of TP cream over fusidic acid cream in the treatment of SBIS are consistent with the results of another recent study^ and suggest that it should be a useful addition to the armamentarium of those treating this common problem. Drug Names (United Kingdom) fusidic acid 2% cream: Fucidin trimethoprim-polymyxin B sulfate cream: Polytrim R. B. Jaafar, M.B. J. H. S. Pettit, M.D., F.R.C.P. Kuala Lumpur, Malaysia and J. R. Gibson, M.B., M.R.C.P. S. G. Harvey, B.Sc. P. Marks, B.Sc. Kent, England References 1. Jaafar RB. Pettit JHS, Gibson JR, et al.: Trimethoprim-polymyxin B sulfate cream versus fusidic acid in the treatment of pyodermas. IntJ Dermatol. 1987;26:60-63. 2. El Mofty M, Harvey SG, Gibson JR, et al.: Trimethoprim-polymyxin B sulphate cream compared with fusidic acid in the treatment of superficial bacterial infection ofthe skin. J Int Med Res. 1990; 18:89-93.
Table 1. Percentage of Patients Completely Healed at Day 8 and Day 15*
Assessment day 8
Symptoms Itching Stinging/burning Pain Signs Erythema Pustules/infeeted bullae Crusts Erosions/ulcerations Tenderness Infiltration/induration Overall assessment of severity
Assessment day 15
TP
Fusidic acid
TP
Fusidic acid
13 63 64
12 62 55
21 79 76
18 70 69
38 63 28 65 75 62 36
36 52 28
59 72
64
63
53
64
84
68 59 32
84t
75 75 70
67
56
86t
50
TP: trimethoprim-polymyxin B sulfate. * Statistically analyzed using Fisher's exact test. t Significantly better than fusidic acid (p < 0.05). 746
October 1991, Vol. 30, No. 10
Trimethoprim-Polymyxin B Sulfate Cream Versus Fusidic Acid Cream in the Treatment of Pyodermas: An Update To the Editor: The interim results of a double-blind study comparing trimethoprimpolymyxin B sulfate (TP) cream versus fusidic acid cream in the treatment of superficial bacterial infection of the skin (SBIS) were published after data from 100 patients had been studied.' We would like to update that report by presenting the full results ofthe study. The study protocol has been previously described.' Two hundred fifty patients (225 men and 25 women) with a clinical diagnosis of SBIS were entered into the study, with equal numbers allocated to each treatment group. The majority of cases were diagnosed as secondarily infected scabies (82%), with other diagnoses including impetigo and secondarily infected insect bites, eczema/dermatitis, and traumatic abrasions. Data from 237 patients were available for analysis and the results are summarized in Table 1. No significant differences between treatments were found at the first follow-up assessment at day 8. At the final follow-up assessment (day 15) comparison ofthe two treatments showed that a significantly higher proportion of patients given TP cream had scores recorded as zero for the signs of tenderness and infiltration/induration (p < 0.05, Fisher's exact test). In addition, all other efficacy trends at day 15 were in favor ofthe TP group. The percentage of patients showing significant improvement (2:50%) was 87% for TP cream and 74% for fusidic acid. Two adverse reactions of a minor nature were reported during the study period (one TP and one fusidic acid).
The final results of this study in 250 (237 evaluable) patients confirm the previously reported interim results from the first 100 (87 evaluable) patients. These results show that TP cream effectively reduces the clinical signs and symptoms of SBIS, and that its use is associated with a low incidence of adverse effects. The efficacy trends in favor of TP cream over fusidic acid cream in the treatment of SBIS are consistent with the results of another recent study^ and suggest that it should be a useful addition to the armamentarium of those treating this common problem. Drug Names (United Kingdom) fusidic acid 2% cream: Fucidin trimethoprim-polymyxin B sulfate cream: Polytrim R. B. Jaafar, M.B. J. H. S. Pettit, M.D., F.R.C.P. Kuala Lumpur, Malaysia and J. R. Gibson, M.B., M.R.C.P. S. G. Harvey, B.Sc. P. Marks, B.Sc. Kent, England References 1. Jaafar RB. Pettit JHS, Gibson JR, et al.: Trimethoprim-polymyxin B sulfate cream versus fusidic acid in the treatment of pyodermas. IntJ Dermatol. 1987;26:60-63. 2. El Mofty M, Harvey SG, Gibson JR, et al.: Trimethoprim-polymyxin B sulphate cream compared with fusidic acid in the treatment of superficial bacterial infection ofthe skin. J Int Med Res. 1990; 18:89-93.
Table 1. Percentage of Patients Completely Healed at Day 8 and Day 15*
Assessment day 8
Symptoms Itching Stinging/burning Pain Signs Erythema Pustules/infeeted bullae Crusts Erosions/ulcerations Tenderness Infiltration/induration Overall assessment of severity
Assessment day 15
TP
Fusidic acid
TP
Fusidic acid
13 63 64
12 62 55
21 79 76
18 70 69
38 63 28 65 75 62 36
36 52 28
59 72
64
63
53
64
84
68 59 32
84t
75 75 70
67
56
86t
50
TP: trimethoprim-polymyxin B sulfate. * Statistically analyzed using Fisher's exact test. t Significantly better than fusidic acid (p < 0.05). 746
October 1991, Vol. 30, No. 10
